TSFAE12:	Subjects With Treatment-emergent Adverse Events Leading to [Dose Modification of Study Treatment] 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 AE 	49 (92.5%) 	53 (72.6%) 	102 (81.0%) 	39 (66.1%) 	26.4 (12.3, 40.4) 	6.5 (-9.3, 22.3) 	
 	 	 	 	 	 	 	
Skin and subcutaneous tissue disorders 	26 (49.1%) 	23 (31.5%) 	49 (38.9%) 	12 (20.3%) 	28.7 (11.8, 45.6) 	11.2 (-3.6, 26.0) 	
PRURITUS 	14 (26.4%) 	12 (16.4%) 	26 (20.6%) 	4 (6.8%) 	19.6 (6.1, 33.1) 	9.7 (-1.0, 20.3) 	
ERYTHEMA 	8 (15.1%) 	6 (8.2%) 	14 (11.1%) 	5 (8.5%) 	6.6 (-5.4, 18.6) 	-0.3 (-9.8, 9.2) 	
HYPERHIDROSIS 	7 (13.2%) 	2 (2.7%) 	9 (7.1%) 	1 (1.7%) 	11.5 (1.8, 21.2) 	1.0 (-3.9, 6.0) 	
RASH 	4 (7.5%) 	5 (6.8%) 	9 (7.1%) 	3 (5.1%) 	2.5 (-6.6, 11.5) 	1.8 (-6.3, 9.8) 	
SKIN IRRITATION 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	2 (3.4%) 	-1.5 (-7.4, 4.4) 	0.7 (-5.8, 7.2) 	
BLISTER 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
RASH PRURITIC 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	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) 	
RASH ERYTHEMATOUS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
RASH MACULO-PAPULAR 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	 	
General disorders and administration site conditions 	23 (43.4%) 	23 (31.5%) 	46 (36.5%) 	12 (20.3%) 	23.1 (6.2, 39.9) 	11.2 (-3.6, 26.0) 	
APPLICATION SITE PRURITUS 	9 (17.0%) 	11 (15.1%) 	20 (15.9%) 	4 (6.8%) 	10.2 (-1.8, 22.2) 	8.3 (-2.1, 18.7) 	
APPLICATION SITE ERYTHEMA 	9 (17.0%) 	6 (8.2%) 	15 (11.9%) 	0 	17.0 (6.9, 27.1) 	8.2 (1.9, 14.5) 	
APPLICATION SITE IRRITATION 	8 (15.1%) 	5 (6.8%) 	13 (10.3%) 	2 (3.4%) 	11.7 (1.0, 22.4) 	3.5 (-3.9, 10.9) 	
FATIGUE 	4 (7.5%) 	3 (4.1%) 	7 (5.6%) 	0 	7.5 (0.4, 14.7) 	4.1 (-0.4, 8.7) 	
APPLICATION SITE DERMATITIS 	2 (3.8%) 	4 (5.5%) 	6 (4.8%) 	3 (5.1%) 	-1.3 (-8.9, 6.3) 	0.4 (-7.3, 8.1) 	
APPLICATION SITE VESICLES 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	0 	3.8 (-1.4, 8.9) 	4.1 (-0.4, 8.7) 	
MALAISE 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	3.8 (-1.4, 8.9) 	1.4 (-1.3, 4.0) 	
APPLICATION SITE PERSPIRATION 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
APPLICATION SITE SWELLING 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
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) 	
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) 	
FEELING COLD 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
OEDEMA PERIPHERAL 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
PYREXIA 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-2.0 (-7.4, 3.3) 	
SUDDEN DEATH 	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) 	
 	 	 	 	 	 	 	
Nervous system disorders 	8 (15.1%) 	10 (13.7%) 	18 (14.3%) 	4 (6.8%) 	8.3 (-3.3, 19.9) 	6.9 (-3.2, 17.1) 	
DIZZINESS 	4 (7.5%) 	4 (5.5%) 	8 (6.3%) 	0 	7.5 (0.4, 14.7) 	5.5 (0.3, 10.7) 	
HEADACHE 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	2 (3.4%) 	2.3 (-5.5, 10.0) 	-0.7 (-6.6, 5.3) 	
TRANSIENT ISCHAEMIC ATTACK 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
BALANCE DISORDER 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
BURNING SENSATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
HEMIANOPIA HOMONYMOUS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
PARAESTHESIA ORAL 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
SOMNOLENCE 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
STUPOR 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
PSYCHOMOTOR HYPERACTIVITY 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Cardiac disorders 	8 (15.1%) 	9 (12.3%) 	17 (13.5%) 	6 (10.2%) 	4.9 (-7.4, 17.3) 	2.2 (-8.6, 12.9) 	
SINUS BRADYCARDIA 	6 (11.3%) 	1 (1.4%) 	7 (5.6%) 	0 	11.3 (2.8, 19.9) 	1.4 (-1.3, 4.0) 	
ATRIAL FIBRILLATION 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
MYOCARDIAL INFARCTION 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	3 (5.1%) 	-3.2 (-9.9, 3.5) 	-3.7 (-9.9, 2.5) 	
VENTRICULAR EXTRASYSTOLES 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
ATRIAL FLUTTER 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
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) 	
PALPITATIONS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
SUPRAVENTRICULAR EXTRASYSTOLES 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
SUPRAVENTRICULAR TACHYCARDIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
WOLFF-PARKINSON-WHITE SYNDROME 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
BUNDLE BRANCH BLOCK LEFT 	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) 	
TACHYCARDIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Gastrointestinal disorders 	9 (17.0%) 	4 (5.5%) 	13 (10.3%) 	4 (6.8%) 	10.2 (-1.8, 22.2) 	-1.3 (-9.6, 7.0) 	
NAUSEA 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	2.7 (-1.0, 6.5) 	
VOMITING 	4 (7.5%) 	0 	4 (3.2%) 	0 	7.5 (0.4, 14.7) 	0.0 (0.0, 0.0) 	
DIARRHOEA 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
SALIVARY HYPERSECRETION 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
ABDOMINAL PAIN 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
CONSTIPATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
DYSPEPSIA 	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) 	
 	 	 	 	 	 	 	
Infections and infestations 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	7 (11.9%) 	-2.4 (-13.8, 9.0) 	-5.0 (-15.1, 5.1) 	
NASOPHARYNGITIS 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	1.0 (-3.9, 6.0) 	
UPPER RESPIRATORY TRACT INFECTION 	2 (3.8%) 	0 	2 (1.6%) 	3 (5.1%) 	-1.3 (-8.9, 6.3) 	-5.1 (-10.7, 0.5) 	
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 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
LOWER RESPIRATORY TRACT INFECTION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PNEUMONIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
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) 	
EAR INFECTION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
GASTROENTERITIS VIRAL 	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) 	
 	 	 	 	 	 	 	
Psychiatric disorders 	3 (5.7%) 	6 (8.2%) 	9 (7.1%) 	4 (6.8%) 	-1.1 (-10.1, 7.8) 	1.4 (-7.6, 10.4) 	
CONFUSIONAL STATE 	0 	3 (4.1%) 	3 (2.4%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	2.4 (-3.2, 8.0) 	
AGITATION 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
DELUSION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
HALLUCINATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
HALLUCINATION, VISUAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
INSOMNIA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
RESTLESSNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
DISTURBANCE IN SEXUAL AROUSAL 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Respiratory, thoracic and mediastinal disorders 	4 (7.5%) 	4 (5.5%) 	8 (6.3%) 	3 (5.1%) 	2.5 (-6.6, 11.5) 	0.4 (-7.3, 8.1) 	
COUGH 	1 (1.9%) 	4 (5.5%) 	5 (4.0%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	3.8 (-2.4, 10.0) 	
NASAL CONGESTION 	2 (3.8%) 	0 	2 (1.6%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	-1.7 (-5.0, 1.6) 	
PRODUCTIVE COUGH 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
RHINORRHOEA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
EMPHYSEMA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Injury, poisoning and procedural complications 	2 (3.8%) 	5 (6.8%) 	7 (5.6%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	3.5 (-3.9, 10.9) 	
EXCORIATION 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
FALL 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
CONTUSION 	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) 	
JOINT DISLOCATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
SKIN LACERATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
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 	3 (5.7%) 	3 (4.1%) 	6 (4.8%) 	3 (5.1%) 	0.6 (-7.8, 8.9) 	-1.0 (-8.2, 6.2) 	
ELECTROCARDIOGRAM T WAVE INVERSION 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
BIOPSY 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
BIOPSY PROSTATE 	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) 	
NASAL MUCOSA BIOPSY 	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) 	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 	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%) 	3 (4.1%) 	6 (4.8%) 	2 (3.4%) 	2.3 (-5.5, 10.0) 	0.7 (-5.8, 7.2) 	
BACK PAIN 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	-0.3 (-4.6, 3.9) 	
ARTHRALGIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
MUSCULAR WEAKNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
MYALGIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
SHOULDER PAIN 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
 	 	 	 	 	 	 	
Eye disorders 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	2 (3.4%) 	-1.5 (-7.4, 4.4) 	-0.7 (-6.6, 5.3) 	
VISION BLURRED 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
CONJUNCTIVAL HAEMORRHAGE 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	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 ALLERGY 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Congenital, familial and genetic disorders 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
VENTRICULAR SEPTAL DEFECT 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
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) 	
 	 	 	 	 	 	 	
Vascular disorders 	0 	2 (2.7%) 	2 (1.6%) 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-0.7 (-6.6, 5.3) 	
HOT FLUSH 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
HYPOTENSION 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-2.0 (-7.4, 3.3) 	
ORTHOSTATIC HYPOTENSION 	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%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
INCREASED APPETITE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
DEHYDRATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Renal and urinary disorders 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
DYSURIA 	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 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
BENIGN PROSTATIC HYPERPLASIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
PELVIC PAIN 	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 	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.