TSFAE24c:	Subjects With Treatment-emergent Adverse Events and Related Treatment-emergent Adverse Events by System Organ Class and Preferred Term; Safety Analysis Set (Study jjcs - core)							
 	AEs 	AEs 	AEs 	Related AEs 	Related AEs 	Related AEs 	
 	Active Study Agent 	Active Study Agent 	 	Active Study Agent 	Active Study Agent 	 	
System Organ Class 	Xanomeline High Dose 	Xanomeline Low Dose 	Placebo 	Xanomeline High Dose 	Xanomeline Low Dose 	Placebo 	
 Preferred Term, n (%) 	N=53 	N=73 	N=59 	N=53 	N=73 	N=59 	
Subjects with ≥ 1 AE 	51 (96.2%) 	62 (84.9%) 	42 (71.2%) 	15 (28.3%) 	19 (26.0%) 	19 (32.2%) 	
 	 	 	 	 	 	 	
Skin and subcutaneous tissue disorders 	34 (64.2%) 	28 (38.4%) 	16 (27.1%) 	1 (1.9%) 	0 	4 (6.8%) 	
PRURITUS 	20 (37.7%) 	14 (19.2%) 	6 (10.2%) 	0 	0 	1 (1.7%) 	
ERYTHEMA 	12 (22.6%) 	8 (11.0%) 	6 (10.2%) 	0 	0 	0 	
HYPERHIDROSIS 	8 (15.1%) 	4 (5.5%) 	2 (3.4%) 	0 	0 	1 (1.7%) 	
RASH 	5 (9.4%) 	9 (12.3%) 	4 (6.8%) 	0 	0 	1 (1.7%) 	
SKIN IRRITATION 	4 (7.5%) 	4 (5.5%) 	3 (5.1%) 	0 	0 	0 	
RASH PRURITIC 	2 (3.8%) 	1 (1.4%) 	0 	0 	0 	0 	
ACTINIC KERATOSIS 	1 (1.9%) 	0 	0 	0 	0 	0 	
BLISTER 	1 (1.9%) 	2 (2.7%) 	0 	0 	0 	0 	
PRURITUS GENERALISED 	1 (1.9%) 	0 	0 	0 	0 	0 	
RASH MACULO-PAPULAR 	1 (1.9%) 	0 	0 	0 	0 	0 	
SKIN ODOUR ABNORMAL 	1 (1.9%) 	0 	0 	1 (1.9%) 	0 	0 	
URTICARIA 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
ALOPECIA 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
DRUG ERUPTION 	0 	0 	1 (1.7%) 	0 	0 	0 	
RASH ERYTHEMATOUS 	0 	1 (1.4%) 	0 	0 	0 	0 	
SKIN ULCER 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
General disorders and administration site conditions 	26 (49.1%) 	38 (52.1%) 	16 (27.1%) 	5 (9.4%) 	6 (8.2%) 	1 (1.7%) 	
APPLICATION SITE PRURITUS 	13 (24.5%) 	18 (24.7%) 	4 (6.8%) 	0 	0 	0 	
APPLICATION SITE ERYTHEMA 	10 (18.9%) 	11 (15.1%) 	2 (3.4%) 	0 	0 	0 	
APPLICATION SITE IRRITATION 	8 (15.1%) 	7 (9.6%) 	2 (3.4%) 	0 	0 	0 	
FATIGUE 	5 (9.4%) 	5 (6.8%) 	0 	1 (1.9%) 	3 (4.1%) 	0 	
APPLICATION SITE DERMATITIS 	4 (7.5%) 	7 (9.6%) 	5 (8.5%) 	0 	0 	0 	
APPLICATION SITE VESICLES 	4 (7.5%) 	4 (5.5%) 	0 	0 	0 	0 	
APPLICATION SITE PAIN 	2 (3.8%) 	0 	0 	0 	0 	0 	
APPLICATION SITE PERSPIRATION 	2 (3.8%) 	0 	0 	0 	0 	0 	
APPLICATION SITE SWELLING 	2 (3.8%) 	1 (1.4%) 	0 	0 	0 	0 	
CHEST PAIN 	2 (3.8%) 	0 	0 	2 (3.8%) 	0 	0 	
MALAISE 	2 (3.8%) 	1 (1.4%) 	0 	1 (1.9%) 	0 	0 	
APPLICATION SITE REACTION 	1 (1.9%) 	0 	1 (1.7%) 	0 	0 	0 	
CHEST DISCOMFORT 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
CHILLS 	1 (1.9%) 	0 	0 	1 (1.9%) 	0 	0 	
FEELING ABNORMAL 	1 (1.9%) 	0 	0 	0 	0 	0 	
FEELING COLD 	1 (1.9%) 	0 	0 	0 	0 	0 	
OEDEMA PERIPHERAL 	1 (1.9%) 	1 (1.4%) 	2 (3.4%) 	0 	1 (1.4%) 	1 (1.7%) 	
PAIN 	1 (1.9%) 	0 	0 	0 	0 	0 	
APPLICATION SITE BLEEDING 	0 	1 (1.4%) 	0 	0 	0 	0 	
APPLICATION SITE DESQUAMATION 	0 	1 (1.4%) 	0 	0 	0 	0 	
APPLICATION SITE INDURATION 	0 	0 	1 (1.7%) 	0 	0 	0 	
APPLICATION SITE URTICARIA 	0 	2 (2.7%) 	0 	0 	0 	0 	
ASTHENIA 	0 	1 (1.4%) 	1 (1.7%) 	0 	1 (1.4%) 	0 	
OEDEMA 	0 	1 (1.4%) 	0 	0 	0 	0 	
PYREXIA 	0 	1 (1.4%) 	2 (3.4%) 	0 	1 (1.4%) 	0 	
SECRETION DISCHARGE 	0 	1 (1.4%) 	0 	0 	0 	0 	
SUDDEN DEATH 	0 	1 (1.4%) 	0 	0 	0 	0 	
ULCER 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Nervous system disorders 	18 (34.0%) 	18 (24.7%) 	5 (8.5%) 	6 (11.3%) 	5 (6.8%) 	1 (1.7%) 	
DIZZINESS 	8 (15.1%) 	8 (11.0%) 	0 	4 (7.5%) 	2 (2.7%) 	0 	
HEADACHE 	5 (9.4%) 	3 (4.1%) 	2 (3.4%) 	2 (3.8%) 	1 (1.4%) 	0 	
BURNING SENSATION 	1 (1.9%) 	0 	0 	0 	0 	0 	
COGNITIVE DISORDER 	1 (1.9%) 	0 	0 	0 	0 	0 	
HYPERSOMNIA 	1 (1.9%) 	0 	0 	0 	0 	0 	
PARAESTHESIA 	1 (1.9%) 	0 	0 	0 	0 	0 	
PAROSMIA 	1 (1.9%) 	0 	0 	0 	0 	0 	
PARTIAL SEIZURES WITH SECONDARY GENERALISATION 	1 (1.9%) 	0 	0 	0 	0 	0 	
SOMNOLENCE 	1 (1.9%) 	2 (2.7%) 	1 (1.7%) 	1 (1.9%) 	1 (1.4%) 	0 	
SYNCOPE 	1 (1.9%) 	3 (4.1%) 	0 	0 	0 	0 	
SYNCOPE VASOVAGAL 	1 (1.9%) 	0 	0 	0 	0 	0 	
TRANSIENT ISCHAEMIC ATTACK 	1 (1.9%) 	2 (2.7%) 	0 	0 	1 (1.4%) 	0 	
BALANCE DISORDER 	0 	1 (1.4%) 	0 	0 	0 	0 	
COMPLEX PARTIAL SEIZURES 	0 	1 (1.4%) 	0 	0 	0 	0 	
COORDINATION ABNORMAL 	0 	1 (1.4%) 	0 	0 	0 	0 	
HEMIANOPIA HOMONYMOUS 	0 	1 (1.4%) 	0 	0 	0 	0 	
LETHARGY 	0 	1 (1.4%) 	0 	0 	0 	0 	
PARAESTHESIA ORAL 	0 	1 (1.4%) 	0 	0 	0 	0 	
PARKINSON'S DISEASE 	0 	0 	1 (1.7%) 	0 	0 	0 	
PSYCHOMOTOR HYPERACTIVITY 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
STUPOR 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Gastrointestinal disorders 	14 (26.4%) 	10 (13.7%) 	7 (11.9%) 	4 (7.5%) 	2 (2.7%) 	2 (3.4%) 	
NAUSEA 	5 (9.4%) 	2 (2.7%) 	0 	2 (3.8%) 	0 	0 	
VOMITING 	5 (9.4%) 	2 (2.7%) 	0 	2 (3.8%) 	0 	0 	
SALIVARY HYPERSECRETION 	4 (7.5%) 	0 	0 	0 	0 	0 	
DIARRHOEA 	2 (3.8%) 	3 (4.1%) 	3 (5.1%) 	1 (1.9%) 	1 (1.4%) 	1 (1.7%) 	
ABDOMINAL DISCOMFORT 	1 (1.9%) 	0 	0 	1 (1.9%) 	0 	0 	
STOMACH DISCOMFORT 	1 (1.9%) 	0 	0 	0 	0 	0 	
ABDOMINAL PAIN 	0 	2 (2.7%) 	1 (1.7%) 	0 	1 (1.4%) 	1 (1.7%) 	
CONSTIPATION 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
DYSPEPSIA 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	0 	
GASTROOESOPHAGEAL REFLUX DISEASE 	0 	0 	1 (1.7%) 	0 	0 	0 	
GLOSSITIS 	0 	0 	1 (1.7%) 	0 	0 	0 	
HIATUS HERNIA 	0 	0 	1 (1.7%) 	0 	0 	0 	
RECTAL HAEMORRHAGE 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Cardiac disorders 	11 (20.8%) 	11 (15.1%) 	7 (11.9%) 	2 (3.8%) 	3 (4.1%) 	3 (5.1%) 	
SINUS BRADYCARDIA 	7 (13.2%) 	4 (5.5%) 	0 	2 (3.8%) 	1 (1.4%) 	0 	
MYOCARDIAL INFARCTION 	3 (5.7%) 	1 (1.4%) 	3 (5.1%) 	0 	0 	2 (3.4%) 	
ATRIAL FIBRILLATION 	1 (1.9%) 	2 (2.7%) 	0 	0 	0 	0 	
ATRIAL FLUTTER 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
CARDIAC DISORDER 	1 (1.9%) 	0 	0 	0 	0 	0 	
VENTRICULAR EXTRASYSTOLES 	1 (1.9%) 	2 (2.7%) 	0 	0 	1 (1.4%) 	0 	
ATRIOVENTRICULAR BLOCK FIRST DEGREE 	0 	1 (1.4%) 	0 	0 	0 	0 	
ATRIOVENTRICULAR BLOCK SECOND DEGREE 	0 	0 	1 (1.7%) 	0 	0 	0 	
BUNDLE BRANCH BLOCK LEFT 	0 	0 	1 (1.7%) 	0 	0 	0 	
BUNDLE BRANCH BLOCK RIGHT 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	
PALPITATIONS 	0 	2 (2.7%) 	0 	0 	1 (1.4%) 	0 	
SINUS ARRHYTHMIA 	0 	0 	1 (1.7%) 	0 	0 	0 	
SUPRAVENTRICULAR EXTRASYSTOLES 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	
SUPRAVENTRICULAR TACHYCARDIA 	0 	1 (1.4%) 	0 	0 	0 	0 	
TACHYCARDIA 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
WOLFF-PARKINSON-WHITE SYNDROME 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Infections and infestations 	9 (17.0%) 	6 (8.2%) 	14 (23.7%) 	0 	0 	4 (6.8%) 	
NASOPHARYNGITIS 	3 (5.7%) 	3 (4.1%) 	2 (3.4%) 	0 	0 	0 	
UPPER RESPIRATORY TRACT INFECTION 	2 (3.8%) 	0 	5 (8.5%) 	0 	0 	3 (5.1%) 	
HORDEOLUM 	1 (1.9%) 	0 	0 	0 	0 	0 	
INFLUENZA 	1 (1.9%) 	1 (1.4%) 	1 (1.7%) 	0 	0 	0 	
LOWER RESPIRATORY TRACT INFECTION 	1 (1.9%) 	0 	0 	0 	0 	0 	
RHINITIS 	1 (1.9%) 	0 	0 	0 	0 	0 	
URINARY TRACT INFECTION 	1 (1.9%) 	0 	2 (3.4%) 	0 	0 	1 (1.7%) 	
BRONCHITIS 	0 	0 	1 (1.7%) 	0 	0 	0 	
CELLULITIS 	0 	1 (1.4%) 	0 	0 	0 	0 	
CERVICITIS 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
EAR INFECTION 	0 	0 	2 (3.4%) 	0 	0 	0 	
GASTROENTERITIS VIRAL 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
LOCALISED INFECTION 	0 	0 	1 (1.7%) 	0 	0 	0 	
PNEUMONIA 	0 	1 (1.4%) 	0 	0 	0 	0 	
VAGINAL MYCOSIS 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
 	 	 	 	 	 	 	
Respiratory, thoracic and mediastinal disorders 	7 (13.2%) 	6 (8.2%) 	5 (8.5%) 	2 (3.8%) 	2 (2.7%) 	2 (3.4%) 	
COUGH 	3 (5.7%) 	4 (5.5%) 	1 (1.7%) 	0 	1 (1.4%) 	1 (1.7%) 	
NASAL CONGESTION 	3 (5.7%) 	0 	2 (3.4%) 	1 (1.9%) 	0 	1 (1.7%) 	
EPISTAXIS 	2 (3.8%) 	0 	0 	1 (1.9%) 	0 	0 	
ALLERGIC GRANULOMATOUS ANGIITIS 	1 (1.9%) 	0 	0 	0 	0 	0 	
PHARYNGOLARYNGEAL PAIN 	1 (1.9%) 	0 	0 	0 	0 	0 	
PRODUCTIVE COUGH 	1 (1.9%) 	0 	0 	0 	0 	0 	
RESPIRATORY TRACT CONGESTION 	1 (1.9%) 	0 	0 	0 	0 	0 	
RHINORRHOEA 	1 (1.9%) 	1 (1.4%) 	0 	0 	1 (1.4%) 	0 	
DYSPHONIA 	0 	1 (1.4%) 	0 	0 	1 (1.4%) 	0 	
DYSPNOEA 	0 	1 (1.4%) 	0 	0 	0 	0 	
EMPHYSEMA 	0 	0 	1 (1.7%) 	0 	0 	0 	
POSTNASAL DRIP 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Psychiatric disorders 	6 (11.3%) 	8 (11.0%) 	7 (11.9%) 	2 (3.8%) 	0 	5 (8.5%) 	
CONFUSIONAL STATE 	1 (1.9%) 	3 (4.1%) 	2 (3.4%) 	1 (1.9%) 	0 	1 (1.7%) 	
DELIRIUM 	1 (1.9%) 	0 	0 	0 	0 	0 	
DELUSION 	1 (1.9%) 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
HALLUCINATION 	1 (1.9%) 	0 	0 	0 	0 	0 	
HALLUCINATION, VISUAL 	1 (1.9%) 	0 	0 	0 	0 	0 	
INSOMNIA 	1 (1.9%) 	0 	1 (1.7%) 	0 	0 	0 	
LIBIDO DECREASED 	1 (1.9%) 	0 	0 	0 	0 	0 	
LISTLESS 	1 (1.9%) 	0 	0 	0 	0 	0 	
NIGHTMARE 	1 (1.9%) 	0 	0 	1 (1.9%) 	0 	0 	
AGITATION 	0 	2 (2.7%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	
ANXIETY 	0 	1 (1.4%) 	0 	0 	0 	0 	
DEPRESSED MOOD 	0 	1 (1.4%) 	0 	0 	0 	0 	
DISORIENTATION 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
DISTURBANCE IN SEXUAL AROUSAL 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
IRRITABILITY 	0 	1 (1.4%) 	0 	0 	0 	0 	
RESTLESSNESS 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Investigations 	5 (9.4%) 	7 (9.6%) 	7 (11.9%) 	0 	1 (1.4%) 	3 (5.1%) 	
BIOPSY 	1 (1.9%) 	0 	0 	0 	0 	0 	
BIOPSY PROSTATE 	1 (1.9%) 	0 	0 	0 	0 	0 	
BLOOD CHOLESTEROL INCREASED 	1 (1.9%) 	0 	0 	0 	0 	0 	
BLOOD GLUCOSE INCREASED 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
ELECTROCARDIOGRAM T WAVE INVERSION 	1 (1.9%) 	1 (1.4%) 	2 (3.4%) 	0 	0 	2 (3.4%) 	
BLOOD ALKALINE PHOSPHATASE INCREASED 	0 	0 	1 (1.7%) 	0 	0 	0 	
BLOOD CREATINE PHOSPHOKINASE INCREASED 	0 	0 	1 (1.7%) 	0 	0 	0 	
BLOOD URINE PRESENT 	0 	0 	1 (1.7%) 	0 	0 	0 	
BODY TEMPERATURE INCREASED 	0 	1 (1.4%) 	0 	0 	0 	0 	
CYSTOSCOPY 	0 	0 	1 (1.7%) 	0 	0 	0 	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 	0 	1 (1.4%) 	3 (5.1%) 	0 	0 	2 (3.4%) 	
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 	0 	1 (1.4%) 	1 (1.7%) 	0 	1 (1.4%) 	1 (1.7%) 	
NASAL MUCOSA BIOPSY 	0 	1 (1.4%) 	0 	0 	0 	0 	
WEIGHT DECREASED 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Musculoskeletal and connective tissue disorders 	4 (7.5%) 	5 (6.8%) 	2 (3.4%) 	1 (1.9%) 	0 	0 	
BACK PAIN 	2 (3.8%) 	1 (1.4%) 	1 (1.7%) 	1 (1.9%) 	0 	0 	
ARTHRALGIA 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
FLANK PAIN 	1 (1.9%) 	0 	0 	0 	0 	0 	
MYALGIA 	1 (1.9%) 	0 	0 	0 	0 	0 	
MUSCLE SPASMS 	0 	1 (1.4%) 	0 	0 	0 	0 	
MUSCULAR WEAKNESS 	0 	1 (1.4%) 	0 	0 	0 	0 	
SHOULDER PAIN 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Injury, poisoning and procedural complications 	3 (5.7%) 	5 (6.8%) 	2 (3.4%) 	1 (1.9%) 	1 (1.4%) 	0 	
CONTUSION 	2 (3.8%) 	1 (1.4%) 	0 	1 (1.9%) 	1 (1.4%) 	0 	
EXCORIATION 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
FACIAL BONES FRACTURE 	1 (1.9%) 	0 	0 	0 	0 	0 	
FALL 	1 (1.9%) 	2 (2.7%) 	1 (1.7%) 	0 	1 (1.4%) 	0 	
HIP FRACTURE 	0 	0 	1 (1.7%) 	0 	0 	0 	
JOINT DISLOCATION 	0 	1 (1.4%) 	0 	0 	0 	0 	
SKIN LACERATION 	0 	2 (2.7%) 	0 	0 	0 	0 	
WOUND 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Reproductive system and breast disorders 	3 (5.7%) 	0 	3 (5.1%) 	0 	0 	0 	
ABNORMAL UTERINE BLEEDING 	1 (1.9%) 	0 	0 	0 	0 	0 	
BENIGN PROSTATIC HYPERPLASIA 	1 (1.9%) 	0 	1 (1.7%) 	0 	0 	0 	
ERECTILE DYSFUNCTION 	1 (1.9%) 	0 	1 (1.7%) 	0 	0 	0 	
PELVIC PAIN 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Renal and urinary disorders 	2 (3.8%) 	3 (4.1%) 	2 (3.4%) 	0 	1 (1.4%) 	1 (1.7%) 	
CALCULUS URETHRAL 	1 (1.9%) 	0 	0 	0 	0 	0 	
NEPHROLITHIASIS 	1 (1.9%) 	0 	0 	0 	0 	0 	
DYSURIA 	0 	1 (1.4%) 	1 (1.7%) 	0 	1 (1.4%) 	1 (1.7%) 	
INCONTINENCE 	0 	1 (1.4%) 	0 	0 	0 	0 	
MICTURITION URGENCY 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Congenital, familial and genetic disorders 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
VENTRICULAR SEPTAL DEFECT 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Ear and labyrinth disorders 	1 (1.9%) 	2 (2.7%) 	1 (1.7%) 	0 	0 	0 	
VERTIGO 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
CERUMEN IMPACTION 	0 	1 (1.4%) 	0 	0 	0 	0 	
EAR PAIN 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Eye disorders 	1 (1.9%) 	2 (2.7%) 	2 (3.4%) 	0 	1 (1.4%) 	2 (3.4%) 	
VISION BLURRED 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
CONJUNCTIVAL HAEMORRHAGE 	0 	1 (1.4%) 	0 	0 	1 (1.4%) 	0 	
CONJUNCTIVITIS 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
EYE ALLERGY 	0 	0 	1 (1.7%) 	0 	0 	0 	
EYE PRURITUS 	0 	0 	1 (1.7%) 	0 	0 	1 (1.7%) 	
EYE SWELLING 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Metabolism and nutrition disorders 	1 (1.9%) 	0 	2 (3.4%) 	1 (1.9%) 	0 	0 	
INCREASED APPETITE 	1 (1.9%) 	0 	0 	1 (1.9%) 	0 	0 	
DECREASED APPETITE 	0 	0 	1 (1.7%) 	0 	0 	0 	
DEHYDRATION 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 	1 (1.9%) 	1 (1.4%) 	0 	0 	0 	0 	
PROSTATE CANCER 	1 (1.9%) 	0 	0 	0 	0 	0 	
COLON CANCER 	0 	1 (1.4%) 	0 	0 	0 	0 	
 	 	 	 	 	 	 	
Surgical and medical procedures 	1 (1.9%) 	0 	2 (3.4%) 	0 	0 	0 	
ACROCHORDON EXCISION 	1 (1.9%) 	0 	0 	0 	0 	0 	
CATARACT OPERATION 	0 	0 	1 (1.7%) 	0 	0 	0 	
EYE LASER SURGERY 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Vascular disorders 	1 (1.9%) 	3 (4.1%) 	3 (5.1%) 	0 	0 	2 (3.4%) 	
WOUND HAEMORRHAGE 	1 (1.9%) 	0 	0 	0 	0 	0 	
HOT FLUSH 	0 	1 (1.4%) 	0 	0 	0 	0 	
HYPERTENSION 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	
HYPOTENSION 	0 	1 (1.4%) 	2 (3.4%) 	0 	0 	1 (1.7%) 	
ORTHOSTATIC HYPOTENSION 	0 	0 	1 (1.7%) 	0 	0 	0 	
 	 	 	 	 	 	 	
Endocrine disorders 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	
BLEEDING ANOVULATORY 	0 	1 (1.4%) 	1 (1.7%) 	0 	0 	1 (1.7%) 	

Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related. 	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.	
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.