Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension (NCT NCT00758524)

Last Updated: 2021-07-06

Results Overview

Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

628 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2021-07-06

Participant Flow

Participants took part at 84 investigative sites in Argentina, Australia, France, Germany, Netherlands, Romania, Spain, Sweden, and the United States from 11 September 2008 to 02 July 2009.

A total of 628 participants were enrolled in the study. Out of 628, only 524 participants with essential hypertension were randomized to receive LCI699 or eplerenone in comparison with placebo for 8 weeks, followed by a randomized withdrawal period to either continue the treatment arm they were randomized to or to take placebo for one additional week (Week 9).

Participant milestones

Participant milestones
Measure	Core Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.25 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period (Week 0 to Week 8) STARTED	92	88	86	97	84	77	0	0	0	0	0	0	0	0	0	0	0
Core Period (Week 0 to Week 8) Treated	92	87	87	97	84	76	0	0	0	0	0	0	0	0	0	0	0
Core Period (Week 0 to Week 8) COMPLETED	84	81	77	90	75	67	0	0	0	0	0	0	0	0	0	0	0
Core Period (Week 0 to Week 8) NOT COMPLETED	8	7	9	7	9	10	0	0	0	0	0	0	0	0	0	0	0
Withdrawal Period (Week 8 to Week 9) STARTED	0	0	0	0	0	0	46	38	44	37	41	37	45	45	39	36	66
Withdrawal Period (Week 8 to Week 9) Randomized Withdrawal Set	0	0	0	0	0	0	45	38	43	37	41	36	45	44	39	36	67
Withdrawal Period (Week 8 to Week 9) COMPLETED	0	0	0	0	0	0	45	38	42	37	41	37	45	45	39	36	66
Withdrawal Period (Week 8 to Week 9) NOT COMPLETED	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Core Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Core Period (Week 0 to Week 8) Reason not Specified	0	1	0	0	0	0	0	0
Core Period (Week 0 to Week 8) Lack of Efficacy	3	2	4	0	3	5	0	0
Core Period (Week 0 to Week 8) Withdrawal by Subject	3	0	2	3	1	3	0	0
Core Period (Week 0 to Week 8) Adverse Event	2	1	1	3	2	1	0	0
Core Period (Week 0 to Week 8) Lost to Follow-up	0	2	1	0	2	1	0	0
Core Period (Week 0 to Week 8) Administrative Problems	0	0	1	1	0	0	0	0
Core Period (Week 0 to Week 8) Abnormal Laboratory Values	0	0	0	0	1	0	0	0
Core Period (Week 0 to Week 8) Abnormal Test Procedure Results	0	1	0	0	0	0	0	0
Withdrawal Period (Week 8 to Week 9) Unsatisfactory Therapeutic Effect	0	0	0	0	0	0	0	2
Withdrawal Period (Week 8 to Week 9) Lost to Follow-up	0	0	0	0	0	0	1	0

Baseline Characteristics

Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=77 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Total n=522 Participants Total of all reporting groups
Blood Pressure 24-hour Ambulatory DBP	90.13 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.893 • n=79 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	89.33 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.208 • n=76 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	91.38 millimeters of mercury (mm Hg) STANDARD_DEVIATION 7.998 • n=80 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	90.81 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.260 • n=78 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	91.14 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.861 • n=71 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	90.11 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.439 • n=66 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	90.49 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.744 • n=450 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.
Age, Continuous	53.9 years STANDARD_DEVIATION 10.5 • n=92 Participants	54.8 years STANDARD_DEVIATION 7.8 • n=87 Participants	54.5 years STANDARD_DEVIATION 9.7 • n=86 Participants	54.4 years STANDARD_DEVIATION 10.8 • n=96 Participants	55.3 years STANDARD_DEVIATION 9.1 • n=84 Participants	53.9 years STANDARD_DEVIATION 8.7 • n=77 Participants	54.5 years STANDARD_DEVIATION 9.50 • n=522 Participants
Sex: Female, Male Female	29 Participants n=92 Participants	29 Participants n=87 Participants	31 Participants n=86 Participants	33 Participants n=96 Participants	28 Participants n=84 Participants	31 Participants n=77 Participants	181 Participants n=522 Participants
Sex: Female, Male Male	63 Participants n=92 Participants	58 Participants n=87 Participants	55 Participants n=86 Participants	63 Participants n=96 Participants	56 Participants n=84 Participants	46 Participants n=77 Participants	341 Participants n=522 Participants
Blood Pressure Clinic Systolic Blood Pressure (SBP)	157.72 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.163 • n=92 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	157.04 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.580 • n=87 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	159.24 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.415 • n=86 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	158.50 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.028 • n=96 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	158.20 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.954 • n=84 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	156.69 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.121 • n=77 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	157.93 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.074 • n=522 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.
Blood Pressure Clinic Diastolic Blood pressure (DBP)	100.43 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.884 • n=92 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	99.94 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.314 • n=87 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	100.03 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.580 • n=86 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	100.21 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.450 • n=96 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	100.39 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.607 • n=84 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	100.54 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.814 • n=77 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	100.25 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.599 • n=522 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.
Blood Pressure 24-hour Ambulatory SBP	141.97 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.167 • n=79 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	140.08 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.502 • n=76 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	143.85 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.613 • n=80 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	142.20 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.079 • n=78 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	143.30 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.989 • n=71 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	142.07 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.150 • n=66 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.	142.25 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.405 • n=450 Participants • Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)	-4.47 mm Hg Standard Error 0.60	-5.50 mm Hg Standard Error 0.57	-7.11 mm Hg Standard Error 0.88	-4.25 mm Hg Standard Error 0.95	-7.49 mm Hg Standard Error 0.97	-3.22 mm Hg Standard Error 0.87	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP	-9.00 mm Hg Standard Error 1.40	-10.69 mm Hg Standard Error 0.98	-11.93 mm Hg Standard Error 1.44	-9.10 mm Hg Standard Error 1.45	-13.31 mm Hg Standard Error 1.48	-2.93 mm Hg Standard Error 1.68	—	—	—	—	—

SECONDARY outcome

Timeframe: AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks

Population: Safety Set included all the participants who received at least 1 dose of study drug.

An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=87 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=97 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths SAEs	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths AEs	23 Participants	22 Participants	24 Participants	27 Participants	26 Participants	23 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8	-4.47 mm Hg Standard Error 0.60	-5.50 mm Hg Standard Error 0.57	-7.11 mm Hg Standard Error 0.88	-4.25 mm Hg Standard Error 0.95	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8	-9.00 mm Hg Standard Error 1.40	-10.69 mm Hg Standard Error 0.98	-11.93 mm Hg Standard Error 1.44	-9.10 mm Hg Standard Error 1.45	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting SBP assessment.

An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=62 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=59 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=68 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=70 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=57 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=52 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM)	-7.15 mm Hg Standard Error 1.20	-4.90 mm Hg Standard Error 1.22	-7.73 mm Hg Standard Error 1.13	-6.18 mm Hg Standard Error 1.14	-10.52 mm Hg Standard Error 1.25	1.11 mm Hg Standard Error 1.30	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting DBP assessment.

An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=62 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=59 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=68 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=70 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=57 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=52 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM	-4.03 mm Hg Standard Error 0.91	-2.44 mm Hg Standard Error 0.92	-4.96 mm Hg Standard Error 0.86	-2.75 mm Hg Standard Error 0.86	-6.03 mm Hg Standard Error 0.94	1.03 mm Hg Standard Error 0.99	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, every hour up to 24 hours post-dose at Week 8

Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=77 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 1	3.91 ratio Standard Error 1.466	2.95 ratio Standard Error 1.541	0.27 ratio Standard Error 1.389	3.87 ratio Standard Error 1.404	0.17 ratio Standard Error 1.544	7.11 ratio Standard Error 1.588	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 2	1.44 ratio Standard Error 1.452	1.85 ratio Standard Error 1.488	0.17 ratio Standard Error 1.397	3.44 ratio Standard Error 1.381	-1.65 ratio Standard Error 1.529	6.28 ratio Standard Error 1.586	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 3	1.16 ratio Standard Error 1.477	1.13 ratio Standard Error 1.502	-0.36 ratio Standard Error 1.387	4.01 ratio Standard Error 1.369	-2.42 ratio Standard Error 1.528	4.99 ratio Standard Error 1.585	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 4	0.51 ratio Standard Error 1.452	2.91 ratio Standard Error 1.488	0.35 ratio Standard Error 1.386	2.64 ratio Standard Error 1.378	-1.39 ratio Standard Error 1.541	7.02 ratio Standard Error 1.584	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 5	1.11 ratio Standard Error 1.463	-0.02 ratio Standard Error 1.513	-1.69 ratio Standard Error 1.385	1.45 ratio Standard Error 1.377	-2.91 ratio Standard Error 1.514	4.31 ratio Standard Error 1.584	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 6	-1.18 ratio Standard Error 1.451	-2.36 ratio Standard Error 1.487	-3.01 ratio Standard Error 1.386	1.20 ratio Standard Error 1.367	-4.86 ratio Standard Error 1.513	1.82 ratio Standard Error 1.585	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 7	-1.85 ratio Standard Error 1.463	-0.95 ratio Standard Error 1.487	-2.63 ratio Standard Error 1.406	1.21 ratio Standard Error 1.366	-3.70 ratio Standard Error 1.513	3.62 ratio Standard Error 1.599	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 8	-3.01 ratio Standard Error 1.464	-1.38 ratio Standard Error 1.487	-2.43 ratio Standard Error 1.396	2.09 ratio Standard Error 1.366	-2.30 ratio Standard Error 1.514	2.65 ratio Standard Error 1.616	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 9	-1.24 ratio Standard Error 1.464	-0.07 ratio Standard Error 1.487	-2.25 ratio Standard Error 1.386	3.27 ratio Standard Error 1.366	-2.81 ratio Standard Error 1.515	3.30 ratio Standard Error 1.600	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 10	-0.59 ratio Standard Error 1.452	2.60 ratio Standard Error 1.487	-1.65 ratio Standard Error 1.385	0.49 ratio Standard Error 1.378	-2.43 ratio Standard Error 1.515	3.86 ratio Standard Error 1.585	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 11	-1.02 ratio Standard Error 1.451	1.72 ratio Standard Error 1.487	-1.54 ratio Standard Error 1.386	1.54 ratio Standard Error 1.367	-1.93 ratio Standard Error 1.514	2.38 ratio Standard Error 1.585	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 12	-1.60 ratio Standard Error 1.451	2.53 ratio Standard Error 1.487	-3.10 ratio Standard Error 1.385	-1.06 ratio Standard Error 1.367	-3.20 ratio Standard Error 1.527	3.24 ratio Standard Error 1.584	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 13	-4.32 ratio Standard Error 1.451	-1.20 ratio Standard Error 1.487	-5.31 ratio Standard Error 1.385	-1.45 ratio Standard Error 1.366	-5.35 ratio Standard Error 1.513	1.52 ratio Standard Error 1.584	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 14	-6.47 ratio Standard Error 1.451	-3.29 ratio Standard Error 1.487	-7.38 ratio Standard Error 1.385	-2.96 ratio Standard Error 1.376	-7.64 ratio Standard Error 1.513	-0.90 ratio Standard Error 1.584	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 15	-8.34 ratio Standard Error 1.452	-5.82 ratio Standard Error 1.488	-8.89 ratio Standard Error 1.386	-6.10 ratio Standard Error 1.377	-9.03 ratio Standard Error 1.527	-1.01 ratio Standard Error 1.586	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 21	-9.31 ratio Standard Error 1.453	-7.68 ratio Standard Error 1.489	-9.66 ratio Standard Error 1.386	-8.22 ratio Standard Error 1.377	-10.51 ratio Standard Error 1.514	-4.12 ratio Standard Error 1.586	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 22	-7.90 ratio Standard Error 1.452	-4.93 ratio Standard Error 1.487	-5.37 ratio Standard Error 1.385	-6.35 ratio Standard Error 1.386	-7.60 ratio Standard Error 1.513	-1.09 ratio Standard Error 1.585	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 23	-4.94 ratio Standard Error 1.475	-1.93 ratio Standard Error 1.487	-1.18 ratio Standard Error 1.385	-2.67 ratio Standard Error 1.377	-5.54 ratio Standard Error 1.513	1.82 ratio Standard Error 1.599	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 24	-0.21 ratio Standard Error 1.477	1.45 ratio Standard Error 1.501	0.29 ratio Standard Error 1.397	1.36 ratio Standard Error 1.370	-2.78 ratio Standard Error 1.529	1.98 ratio Standard Error 1.617	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 16	-8.92 ratio Standard Error 1.465	-8.37 ratio Standard Error 1.491	-10.50 ratio Standard Error 1.387	-9.54 ratio Standard Error 1.369	-12.55 ratio Standard Error 1.528	-1.61 ratio Standard Error 1.587	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 17	-10.26 ratio Standard Error 1.454	-10.99 ratio Standard Error 1.492	-12.71 ratio Standard Error 1.398	-10.38 ratio Standard Error 1.380	-12.88 ratio Standard Error 1.516	-4.20 ratio Standard Error 1.604	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 18	-10.68 ratio Standard Error 1.456	-11.73 ratio Standard Error 1.492	-11.88 ratio Standard Error 1.389	-11.85 ratio Standard Error 1.379	-13.49 ratio Standard Error 1.529	-6.89 ratio Standard Error 1.587	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 19	-10.13 ratio Standard Error 1.456	-10.12 ratio Standard Error 1.493	-9.74 ratio Standard Error 1.388	-10.78 ratio Standard Error 1.369	-10.13 ratio Standard Error 1.517	-5.84 ratio Standard Error 1.587	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 Week 8, Hour 20	-10.73 ratio Standard Error 1.454	-8.06 ratio Standard Error 1.504	-10.43 ratio Standard Error 1.408	-10.49 ratio Standard Error 1.369	-10.47 ratio Standard Error 1.516	-5.21 ratio Standard Error 1.602	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, every hour up to 24 hours post-dose at Week 8

Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=77 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 9	-3.98 ratio Standard Error 1.766	-1.59 ratio Standard Error 1.795	-4.78 ratio Standard Error 1.672	-1.87 ratio Standard Error 1.649	-7.46 ratio Standard Error 1.828	2.39 ratio Standard Error 1.931	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 1	-0.54 ratio Standard Error 1.767	0.09 ratio Standard Error 1.859	-4.51 ratio Standard Error 1.674	-1.42 ratio Standard Error 1.690	-5.33 ratio Standard Error 1.863	8.23 ratio Standard Error 1.915	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 2	-1.59 ratio Standard Error 1.752	0.15 ratio Standard Error 1.795	-3.56 ratio Standard Error 1.685	-0.57 ratio Standard Error 1.663	-5.90 ratio Standard Error 1.844	6.48 ratio Standard Error 1.913	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 3	-2.11 ratio Standard Error 1.781	-1.53 ratio Standard Error 1.811	-4.86 ratio Standard Error 1.672	0.91 ratio Standard Error 1.649	-5.89 ratio Standard Error 1.843	4.60 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 4	-2.06 ratio Standard Error 1.752	-1.18 ratio Standard Error 1.794	-4.15 ratio Standard Error 1.672	1.50 ratio Standard Error 1.661	-5.12 ratio Standard Error 1.859	4.68 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 5	-4.29 ratio Standard Error 1.766	-3.09 ratio Standard Error 1.825	-3.47 ratio Standard Error 1.671	-1.70 ratio Standard Error 1.660	-7.22 ratio Standard Error 1.826	2.78 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 6	-4.21 ratio Standard Error 1.751	-3.12 ratio Standard Error 1.794	-5.88 ratio Standard Error 1.672	-1.02 ratio Standard Error 1.648	-7.91 ratio Standard Error 1.826	1.42 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 7	-4.95 ratio Standard Error 1.766	-2.10 ratio Standard Error 1.794	-5.40 ratio Standard Error 1.697	-0.76 ratio Standard Error 1.649	-8.70 ratio Standard Error 1.826	2.25 ratio Standard Error 1.930	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 8	-5.28 ratio Standard Error 1.766	-4.69 ratio Standard Error 1.794	-5.30 ratio Standard Error 1.684	-3.02 ratio Standard Error 1.649	-8.06 ratio Standard Error 1.827	3.76 ratio Standard Error 1.950	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 13	-6.45 ratio Standard Error 1.751	-2.30 ratio Standard Error 1.794	-7.25 ratio Standard Error 1.671	-4.05 ratio Standard Error 1.649	-8.81 ratio Standard Error 1.826	3.20 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 14	-7.37 ratio Standard Error 1.751	-5.68 ratio Standard Error 1.794	-9.33 ratio Standard Error 1.671	-6.12 ratio Standard Error 1.660	-10.91 ratio Standard Error 1.826	0.75 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 15	-10.61 ratio Standard Error 1.752	-8.28 ratio Standard Error 1.795	-11.26 ratio Standard Error 1.672	-9.78 ratio Standard Error 1.661	-12.04 ratio Standard Error 1.842	0.02 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 16	-11.71 ratio Standard Error 1.767	-10.01 ratio Standard Error 1.797	-12.63 ratio Standard Error 1.672	-13.03 ratio Standard Error 1.651	-16.68 ratio Standard Error 1.843	-0.33 ratio Standard Error 1.914	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 10	-3.69 ratio Standard Error 1.752	-0.30 ratio Standard Error 1.794	-3.40 ratio Standard Error 1.672	-1.73 ratio Standard Error 1.662	-7.35 ratio Standard Error 1.828	2.54 ratio Standard Error 1.913	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 11	-2.47 ratio Standard Error 1.751	-0.43 ratio Standard Error 1.795	-4.22 ratio Standard Error 1.672	-1.74 ratio Standard Error 1.649	-5.75 ratio Standard Error 1.827	3.51 ratio Standard Error 1.913	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 12	-5.19 ratio Standard Error 1.752	0.73 ratio Standard Error 1.794	-4.35 ratio Standard Error 1.671	-3.92 ratio Standard Error 1.650	-6.25 ratio Standard Error 1.843	4.69 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 17	-13.71 ratio Standard Error 1.754	-11.96 ratio Standard Error 1.799	-15.46 ratio Standard Error 1.685	-13.72 ratio Standard Error 1.664	-19.59 ratio Standard Error 1.828	-3.03 ratio Standard Error 1.933	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 18	-14.49 ratio Standard Error 1.756	-14.37 ratio Standard Error 1.800	-14.54 ratio Standard Error 1.675	-15.60 ratio Standard Error 1.664	-18.55 ratio Standard Error 1.844	-6.35 ratio Standard Error 1.915	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 19	-13.78 ratio Standard Error 1.756	-13.08 ratio Standard Error 1.801	-12.85 ratio Standard Error 1.674	-15.93 ratio Standard Error 1.652	-15.49 ratio Standard Error 1.830	-6.98 ratio Standard Error 1.914	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 20	-13.92 ratio Standard Error 1.756	-13.22 ratio Standard Error 1.814	-12.54 ratio Standard Error 1.699	-15.47 ratio Standard Error 1.652	-16.09 ratio Standard Error 1.829	-6.53 ratio Standard Error 1.934	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 21	-14.33 ratio Standard Error 1.754	-10.06 ratio Standard Error 1.797	-12.78 ratio Standard Error 1.672	-13.63 ratio Standard Error 1.662	-15.34 ratio Standard Error 1.827	-3.89 ratio Standard Error 1.914	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 22	-13.46 ratio Standard Error 1.752	-8.35 ratio Standard Error 1.794	-7.52 ratio Standard Error 1.671	-10.55 ratio Standard Error 1.673	-12.47 ratio Standard Error 1.826	-0.94 ratio Standard Error 1.912	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 23	-7.88 ratio Standard Error 1.780	-6.23 ratio Standard Error 1.794	-5.77 ratio Standard Error 1.671	-6.73 ratio Standard Error 1.661	-9.02 ratio Standard Error 1.826	2.18 ratio Standard Error 1.930	—	—	—	—	—
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 Week 8, Hour 24	-3.16 ratio Standard Error 1.781	-0.64 ratio Standard Error 1.810	-3.45 ratio Standard Error 1.685	-3.76 ratio Standard Error 1.651	-8.90 ratio Standard Error 1.844	0.70 ratio Standard Error 1.951	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Safety Set included all the participants who received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=71 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=69 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=70 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=76 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=64 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=54 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8	-21.5 picomoles per liter (pmol/L) Standard Deviation 122	-20.0 picomoles per liter (pmol/L) Standard Deviation 156	-9.9 picomoles per liter (pmol/L) Standard Deviation 266	-47.5 picomoles per liter (pmol/L) Standard Deviation 170	277.1 picomoles per liter (pmol/L) Standard Deviation 429	-28.8 picomoles per liter (pmol/L) Standard Deviation 163	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF MSDBP Control	32.6 percentage of participants	29.4 percentage of participants	41.9 percentage of participants	29.2 percentage of participants	45.2 percentage of participants	18.4 percentage of participants	—	—	—	—	—
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF MSDBP Response	39.1 percentage of participants	34.1 percentage of participants	50.0 percentage of participants	34.4 percentage of participants	48.8 percentage of participants	27.6 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=92 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=85 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=86 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=96 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF MSSBP Response	39.1 percentage of participants	37.6 percentage of participants	48.8 percentage of participants	34.4 percentage of participants	52.4 percentage of participants	17.1 percentage of participants	—	—	—	—	—
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF MSSBP Control	31.5 percentage of participants	27.1 percentage of participants	40.7 percentage of participants	25.0 percentage of participants	44.0 percentage of participants	15.8 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 hour post-dose at Week 8

Population: ACTH subset population included all participants prior to treatment with LCI699 and at the end of the treatment interval (Week 8). Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure at the given timepoint

The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was \<500 nanomoles per liter (nmol/L) at 1 hour after the injection.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=20 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=23 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=28 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=24 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=22 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=17 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test	729.20 nanomoles per liter (nmol/L) Standard Deviation 123.753	692.74 nanomoles per liter (nmol/L) Standard Deviation 117.645	604.46 nanomoles per liter (nmol/L) Standard Deviation 125.017	609.21 nanomoles per liter (nmol/L) Standard Deviation 107.923	802.32 nanomoles per liter (nmol/L) Standard Deviation 134.497	822.65 nanomoles per liter (nmol/L) Standard Deviation 116.041	—	—	—	—	—

SECONDARY outcome

Timeframe: From Week 8 to Week 9

Population: Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=45 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=38 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=43 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=37 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=41 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=36 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID n=45 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo n=44 Participants Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID n=39 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo n=36 Participants Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo n=67 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP	0.5 mm Hg Standard Error 0.99	0.5 mm Hg Standard Error 1.08	1.6 mm Hg Standard Error 1.01	-0.2 mm Hg Standard Error 1.09	-0.5 mm Hg Standard Error 1.03	2.5 mm Hg Standard Error 1.11	1.3 mm Hg Standard Error 1.00	1.3 mm Hg Standard Error 1.02	-1.2 mm Hg Standard Error 1.06	0.4 mm Hg Standard Error 1.11	1.6 mm Hg Standard Error 0.83

SECONDARY outcome

Timeframe: From Week 8 to Week 9

Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.

Outcome measures

Outcome measures
Measure	Core Period: LCI699 0.25 mg QD n=45 Participants Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=38 Participants Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=43 Participants Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=37 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=41 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=36 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.5 mg BID n=45 Participants Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo n=44 Participants Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID n=39 Participants Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo n=36 Participants Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo n=67 Participants Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP	0.3 mm Hg Standard Error 1.66	3.3 mm Hg Standard Error 1.80	0.5 mm Hg Standard Error 1.69	2.5 mm Hg Standard Error 1.82	0.4 mm Hg Standard Error 1.72	5.3 mm Hg Standard Error 1.85	1.6 mm Hg Standard Error 1.68	4.4 mm Hg Standard Error 1.69	-1.5 mm Hg Standard Error 1.79	2.7 mm Hg Standard Error 1.86	1.8 mm Hg Standard Error 1.39

Adverse Events

Core Period: LCI699 0.25 mg QD

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Core Period: LCI699 0.5 mg QD

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Core Period: LCI699 1.0 mg QD

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Core Period: LCI699 0.5 mg BID

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Core Period: Eplerenone 50 mg BID

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Core Period: Placebo

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.25 mg QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.25 mg QD Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.5 mg QD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.5 mg QD Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 1.0 mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 1.0 mg QD Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.5 mg BID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Withdrawal Period: LCI699 0.5 mg BID Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Withdrawal Period: Eplerenone 50 mg BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Withdrawal Period: Eplerenone 50 mg BID Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Withdrawal Period: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Core Period: LCI699 0.25 mg QD n=92 participants at risk Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 participants at risk Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=87 participants at risk Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=97 participants at risk Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 participants at risk Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 participants at risk Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.25 mg QD n=46 participants at risk Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.25 mg QD Placebo n=38 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD n=44 participants at risk Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD Placebo n=37 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD n=41 participants at risk Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD Placebo n=37 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID n=45 participants at risk Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo n=45 participants at risk Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID n=39 participants at risk Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo n=36 participants at risk Participants received eplerenone-matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo n=66 participants at risk Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Eye disorders Retinal vein occlusion	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Abdominal pain	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.

Other adverse events

Other adverse events
Measure	Core Period: LCI699 0.25 mg QD n=92 participants at risk Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg QD n=87 participants at risk Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 1.0 mg QD n=87 participants at risk Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Core Period: LCI699 0.5 mg BID n=97 participants at risk Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Eplerenone 50 mg BID n=84 participants at risk Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Core Period: Placebo n=76 participants at risk Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Withdrawal Period: LCI699 0.25 mg QD n=46 participants at risk Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.25 mg QD Placebo n=38 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD n=44 participants at risk Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg QD Placebo n=37 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD n=41 participants at risk Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 1.0 mg QD Placebo n=37 participants at risk Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID n=45 participants at risk Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: LCI699 0.5 mg BID Placebo n=45 participants at risk Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID n=39 participants at risk Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Eplerenone 50 mg BID Placebo n=36 participants at risk Participants received eplerenone-matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Withdrawal Period: Placebo n=66 participants at risk Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Gastrointestinal disorders Vomiting	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Angina pectoris	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Bradycardia	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Palpitations	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Sinus bradycardia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Tachycardia	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Congenital, familial and genetic disorders Talipes	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Ear and labyrinth disorders Tinnitus	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Eye disorders Conjunctivitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Eye disorders Glaucoma	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Eye disorders Vision blurred	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Eye disorders Visual impairment	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Abdominal pain	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.7% 1/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 2/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Constipation	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Diarrhoea	2.2% 2/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Dry mouth	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Dyspepsia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Enterocolitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Flatulence	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Gingivitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Nausea	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Oral pain	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Gastrointestinal disorders Toothache	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Asthenia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.1% 2/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Chest discomfort	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Fatigue	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.1% 2/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Irritability	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Malaise	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Non-cardiac chest pain	2.2% 2/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Oedema peripheral	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 1/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
General disorders Pyrexia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Hepatobiliary disorders Biliary colic	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Immune system disorders Seasonal allergy	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Acarodermatitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Acute tonsillitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Bronchitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Bronchitis bacterial	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Influenza	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 2/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Nasopharyngitis	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 2/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	3.4% 3/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	4.8% 4/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	3.9% 3/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Pharyngitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Pneumonia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Respiratory tract infection viral	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Rhinitis	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Sialoadenitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.5% 1/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Sinusitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 2/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Tooth abscess	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Tracheitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Tracheobronchitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Upper respiratory tract infection	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Urinary tract infection	2.2% 2/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Infections and infestations Viral infection	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Injury, poisoning and procedural complications Contusion	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.4% 1/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Injury, poisoning and procedural complications Joint sprain	2.2% 2/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.7% 1/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Investigations Weight decreased	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Anorexia	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Gout	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Metabolism and nutrition disorders Increased appetite	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 1/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 1/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Bursitis	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.7% 1/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.5% 1/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Polyarthritis	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Carpal tunnel syndrome	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Complex regional pain syndrome	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Dizziness	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 2/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	5.2% 5/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Dizziness postural	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Headache	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	4.6% 4/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.1% 2/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	3.6% 3/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	13.2% 10/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.7% 1/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Migraine	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Paraesthesia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Somnolence	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Syncope	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.7% 1/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Nervous system disorders Trigeminal neuralgia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.5% 1/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Psychiatric disorders Anxiety	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Psychiatric disorders Depression	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Psychiatric disorders Insomnia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 2/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Psychiatric disorders Stress	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Renal and urinary disorders Nocturia	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Renal and urinary disorders Urinary incontinence	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Reproductive system and breast disorders Ejaculation disorder	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.4% 1/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.6% 1/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.4% 1/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.4% 2/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.2% 1/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Erythema	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.2% 1/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Rash	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	2.3% 1/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Skin striae	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.1% 1/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Vascular disorders Hypertensive crisis	1.1% 1/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.3% 1/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
Vascular disorders Raynaud's phenomenon	0.00% 0/92 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/87 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	1.0% 1/97 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/84 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/76 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/46 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/38 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/44 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/41 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/37 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/45 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/39 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/36 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.	0.00% 0/66 • AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 8627788300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER