TSFAE03:	Subjects With Treatment-emergent Serious Adverse Events by System Organ Class and Preferred Term; Safety Analysis Set (Study jjcs - core)							
 	Active Study Agent 	Active Study Agent 	Active Study Agent 	 	Risk Difference (%) (95% CI) 	Risk Difference (%) (95% CI) 	
System Organ Class 	Xanomeline High Dose 	Xanomeline Low Dose 	Combined 	Placebo 	Xanomeline High Dose vs Placebo 	Xanomeline Low Dose vs Placebo 	
  Preferred Term, n (%) 	N=53 	N=73 	N=126 	N=59 	  	  	
Subjects with ≥1 SAE 	47 (88.7%) 	54 (74.0%) 	101 (80.2%) 	37 (62.7%) 	26.0 (11.0, 41.0) 	11.3 (-4.7, 27.2) 	
 	 	 	 	 	 	 	
General disorders and administration site conditions 	21 (39.6%) 	28 (38.4%) 	49 (38.9%) 	11 (18.6%) 	21.0 (4.5, 37.5) 	19.7 (4.8, 34.7) 	
APPLICATION SITE PRURITUS 	9 (17.0%) 	10 (13.7%) 	19 (15.1%) 	3 (5.1%) 	11.9 (0.3, 23.5) 	8.6 (-1.1, 18.3) 	
APPLICATION SITE ERYTHEMA 	8 (15.1%) 	8 (11.0%) 	16 (12.7%) 	1 (1.7%) 	13.4 (3.2, 23.6) 	9.3 (1.4, 17.2) 	
APPLICATION SITE IRRITATION 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	2 (3.4%) 	6.0 (-3.1, 15.2) 	3.5 (-3.9, 10.9) 	
APPLICATION SITE DERMATITIS 	3 (5.7%) 	4 (5.5%) 	7 (5.6%) 	4 (6.8%) 	-1.1 (-10.1, 7.8) 	-1.3 (-9.6, 7.0) 	
APPLICATION SITE VESICLES 	4 (7.5%) 	1 (1.4%) 	5 (4.0%) 	0 	7.5 (0.4, 14.7) 	1.4 (-1.3, 4.0) 	
FATIGUE 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	2.7 (-1.0, 6.5) 	
APPLICATION SITE SWELLING 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
MALAISE 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
OEDEMA PERIPHERAL 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	-1.5 (-7.4, 4.4) 	-2.0 (-7.4, 3.3) 	
APPLICATION SITE BLEEDING 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
APPLICATION SITE DESQUAMATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
APPLICATION SITE PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
APPLICATION SITE REACTION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
APPLICATION SITE URTICARIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
CHEST DISCOMFORT 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
CHEST PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
CHILLS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
FEELING ABNORMAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PYREXIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
SUDDEN DEATH 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
ULCER 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
ASTHENIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Skin and subcutaneous tissue disorders 	27 (50.9%) 	21 (28.8%) 	48 (38.1%) 	13 (22.0%) 	28.9 (11.8, 46.0) 	6.7 (-8.1, 21.6) 	
PRURITUS 	12 (22.6%) 	10 (13.7%) 	22 (17.5%) 	3 (5.1%) 	17.6 (5.0, 30.1) 	8.6 (-1.1, 18.3) 	
ERYTHEMA 	9 (17.0%) 	6 (8.2%) 	15 (11.9%) 	4 (6.8%) 	10.2 (-1.8, 22.2) 	1.4 (-7.6, 10.4) 	
HYPERHIDROSIS 	5 (9.4%) 	4 (5.5%) 	9 (7.1%) 	2 (3.4%) 	6.0 (-3.1, 15.2) 	2.1 (-4.9, 9.1) 	
RASH 	2 (3.8%) 	4 (5.5%) 	6 (4.8%) 	4 (6.8%) 	-3.0 (-11.2, 5.2) 	-1.3 (-9.6, 7.0) 	
SKIN IRRITATION 	3 (5.7%) 	3 (4.1%) 	6 (4.8%) 	3 (5.1%) 	0.6 (-7.8, 8.9) 	-1.0 (-8.2, 6.2) 	
RASH PRURITIC 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	3.8 (-1.4, 8.9) 	1.4 (-1.3, 4.0) 	
URTICARIA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
BLISTER 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
PRURITUS GENERALISED 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
RASH MACULO-PAPULAR 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
DRUG ERUPTION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
SKIN ULCER 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Nervous system disorders 	11 (20.8%) 	10 (13.7%) 	21 (16.7%) 	3 (5.1%) 	15.7 (3.4, 27.9) 	8.6 (-1.1, 18.3) 	
DIZZINESS 	4 (7.5%) 	3 (4.1%) 	7 (5.6%) 	0 	7.5 (0.4, 14.7) 	4.1 (-0.4, 8.7) 	
HEADACHE 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	2.4 (-3.2, 8.0) 	
SOMNOLENCE 	0 	2 (2.7%) 	2 (1.6%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	1.0 (-3.9, 6.0) 	
TRANSIENT ISCHAEMIC ATTACK 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
BURNING SENSATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
COGNITIVE DISORDER 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
COORDINATION ABNORMAL 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
HEMIANOPIA HOMONYMOUS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
LETHARGY 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
PAROSMIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PARTIAL SEIZURES WITH SECONDARY GENERALISATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
STUPOR 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
SYNCOPE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PARKINSON'S DISEASE 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Gastrointestinal disorders 	10 (18.9%) 	5 (6.8%) 	15 (11.9%) 	4 (6.8%) 	12.1 (-0.2, 24.4) 	0.1 (-8.6, 8.7) 	
DIARRHOEA 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	1.0 (-3.9, 6.0) 	
SALIVARY HYPERSECRETION 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
VOMITING 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
NAUSEA 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
ABDOMINAL DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
ABDOMINAL PAIN 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
DYSPEPSIA 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
RECTAL HAEMORRHAGE 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
STOMACH DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
CONSTIPATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
GASTROOESOPHAGEAL REFLUX DISEASE 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
GLOSSITIS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Cardiac disorders 	6 (11.3%) 	7 (9.6%) 	13 (10.3%) 	5 (8.5%) 	2.8 (-8.3, 13.9) 	1.1 (-8.7, 10.9) 	
SINUS BRADYCARDIA 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	2.7 (-1.0, 6.5) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
ATRIAL FLUTTER 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
VENTRICULAR EXTRASYSTOLES 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
BUNDLE BRANCH BLOCK RIGHT 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
WOLFF-PARKINSON-WHITE SYNDROME 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
ATRIOVENTRICULAR BLOCK SECOND DEGREE 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
SINUS ARRHYTHMIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
SUPRAVENTRICULAR EXTRASYSTOLES 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
TACHYCARDIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Infections and infestations 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	10 (16.9%) 	-7.5 (-19.9, 4.9) 	-10.1 (-21.3, 1.1) 	
NASOPHARYNGITIS 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	0.7 (-5.8, 7.2) 	
CELLULITIS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
HORDEOLUM 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
INFLUENZA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
PNEUMONIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
RHINITIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
UPPER RESPIRATORY TRACT INFECTION 	1 (1.9%) 	0 	1 (0.8%) 	3 (5.1%) 	-3.2 (-9.9, 3.5) 	-5.1 (-10.7, 0.5) 	
BRONCHITIS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
CERVICITIS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
LOCALISED INFECTION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
URINARY TRACT INFECTION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
VAGINAL MYCOSIS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Respiratory, thoracic and mediastinal disorders 	6 (11.3%) 	3 (4.1%) 	9 (7.1%) 	1 (1.7%) 	9.6 (0.5, 18.8) 	2.4 (-3.2, 8.0) 	
COUGH 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	3.8 (-1.4, 8.9) 	1.4 (-1.3, 4.0) 	
RHINORRHOEA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
ALLERGIC GRANULOMATOUS ANGIITIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
DYSPHONIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
EPISTAXIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
NASAL CONGESTION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PRODUCTIVE COUGH 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
POSTNASAL DRIP 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Injury, poisoning and procedural complications 	1 (1.9%) 	5 (6.8%) 	6 (4.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	5.2 (-1.5, 11.8) 	
FALL 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	1.9 (-1.8, 5.5) 	2.7 (-1.0, 6.5) 	
SKIN LACERATION 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
CONTUSION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
EXCORIATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
FACIAL BONES FRACTURE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
WOUND 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
HIP FRACTURE 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Investigations 	2 (3.8%) 	4 (5.5%) 	6 (4.8%) 	7 (11.9%) 	-8.1 (-17.8, 1.6) 	-6.4 (-16.1, 3.4) 	
BLOOD CHOLESTEROL INCREASED 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
BLOOD GLUCOSE INCREASED 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
BODY TEMPERATURE INCREASED 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 	0 	1 (1.4%) 	1 (0.8%) 	3 (5.1%) 	-5.1 (-10.7, 0.5) 	-3.7 (-9.9, 2.5) 	
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
WEIGHT DECREASED 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
BLOOD ALKALINE PHOSPHATASE INCREASED 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
BLOOD CREATINE PHOSPHOKINASE INCREASED 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
BLOOD URINE PRESENT 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
ELECTROCARDIOGRAM T WAVE INVERSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Musculoskeletal and connective tissue disorders 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	2.7 (-1.0, 6.5) 	
BACK PAIN 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
ARTHRALGIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
FLANK PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
MUSCLE SPASMS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
MUSCULAR WEAKNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
Psychiatric disorders 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	4 (6.8%) 	-3.0 (-11.2, 5.2) 	-2.7 (-10.5, 5.2) 	
CONFUSIONAL STATE 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
ANXIETY 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
INSOMNIA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
LIBIDO DECREASED 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
LISTLESS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
RESTLESSNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
AGITATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
DELUSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Renal and urinary disorders 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	1.0 (-3.9, 6.0) 	
CALCULUS URETHRAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
DYSURIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
INCONTINENCE 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
MICTURITION URGENCY 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Reproductive system and breast disorders 	3 (5.7%) 	0 	3 (2.4%) 	3 (5.1%) 	0.6 (-7.8, 8.9) 	-5.1 (-10.7, 0.5) 	
ABNORMAL UTERINE BLEEDING 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
BENIGN PROSTATIC HYPERPLASIA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
ERECTILE DYSFUNCTION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
PELVIC PAIN 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Ear and labyrinth disorders 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
CERUMEN IMPACTION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
VERTIGO 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
Eye disorders 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	-1.5 (-7.4, 4.4) 	-2.0 (-7.4, 3.3) 	
VISION BLURRED 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
CONJUNCTIVITIS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
EYE PRURITUS 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Endocrine disorders 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
BLEEDING ANOVULATORY 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
Metabolism and nutrition disorders 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
INCREASED APPETITE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	 	
Vascular disorders 	1 (1.9%) 	0 	1 (0.8%) 	2 (3.4%) 	-1.5 (-7.4, 4.4) 	-3.4 (-8.0, 1.2) 	
WOUND HAEMORRHAGE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
HYPOTENSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
ORTHOSTATIC HYPOTENSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Surgical and medical procedures 	0 	0 	0 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-3.4 (-8.0, 1.2) 	
CATARACT OPERATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
EYE LASER SURGERY 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	

Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. 	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.	
Note: Adverse events are coded using MedDRA version 26.0. 	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.