TSFAE21c:	Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Severity; Safety Analysis Set (Study jjcs - core)					
 	Active Study Agent 	Active Study Agent 	Active Study Agent 	 	
System Organ Class 	Xanomeline High Dose 	Xanomeline Low Dose 	Combined 	Placebo 	
  Preferred Term, n (%) 	N=53 	N=73 	N=126 	N=59 	
Subjects with ≥1 AE 	51 (96.2%) 	62 (84.9%) 	113 (89.7%) 	42 (71.2%) 	
 	 	 	 	 	
General disorders and administration site conditions 	26 (49.1%) 	38 (52.1%) 	64 (50.8%) 	16 (27.1%) 	
APPLICATION SITE PRURITUS 	13 (24.5%) 	18 (24.7%) 	31 (24.6%) 	4 (6.8%) 	
Mild 	7 (13.2%) 	11 (15.1%) 	18 (14.3%) 	3 (5.1%) 	
Moderate 	6 (11.3%) 	7 (9.6%) 	13 (10.3%) 	1 (1.7%) 	
 	 	 	 	 	
APPLICATION SITE ERYTHEMA 	10 (18.9%) 	11 (15.1%) 	21 (16.7%) 	2 (3.4%) 	
Mild 	7 (13.2%) 	4 (5.5%) 	11 (8.7%) 	2 (3.4%) 	
Moderate 	3 (5.7%) 	6 (8.2%) 	9 (7.1%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE IRRITATION 	8 (15.1%) 	7 (9.6%) 	15 (11.9%) 	2 (3.4%) 	
Mild 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	
Moderate 	5 (9.4%) 	3 (4.1%) 	8 (6.3%) 	2 (3.4%) 	
Severe 	0 	2 (2.7%) 	2 (1.6%) 	0 	
 	 	 	 	 	
APPLICATION SITE DERMATITIS 	4 (7.5%) 	7 (9.6%) 	11 (8.7%) 	5 (8.5%) 	
Mild 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	5 (8.5%) 	
Moderate 	2 (3.8%) 	4 (5.5%) 	6 (4.8%) 	0 	
 	 	 	 	 	
FATIGUE 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	0 	
Mild 	5 (9.4%) 	3 (4.1%) 	8 (6.3%) 	0 	
Moderate 	0 	2 (2.7%) 	2 (1.6%) 	0 	
 	 	 	 	 	
APPLICATION SITE VESICLES 	4 (7.5%) 	4 (5.5%) 	8 (6.3%) 	0 	
Mild 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	0 	
Moderate 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	0 	
 	 	 	 	 	
APPLICATION SITE SWELLING 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
MALAISE 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE PAIN 	2 (3.8%) 	0 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE PERSPIRATION 	2 (3.8%) 	0 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE URTICARIA 	0 	2 (2.7%) 	2 (1.6%) 	0 	
Mild 	0 	2 (2.7%) 	2 (1.6%) 	0 	
 	 	 	 	 	
CHEST DISCOMFORT 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
CHEST PAIN 	2 (3.8%) 	0 	2 (1.6%) 	0 	
Mild 	2 (3.8%) 	0 	2 (1.6%) 	0 	
 	 	 	 	 	
OEDEMA PERIPHERAL 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	
Mild 	0 	0 	0 	2 (3.4%) 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
APPLICATION SITE BLEEDING 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE DESQUAMATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE REACTION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
ASTHENIA 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
CHILLS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
FEELING ABNORMAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
FEELING COLD 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
OEDEMA 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PYREXIA 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	
 	 	 	 	 	
SECRETION DISCHARGE 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
SUDDEN DEATH 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ULCER 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
APPLICATION SITE INDURATION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Skin and subcutaneous tissue disorders 	34 (64.2%) 	28 (38.4%) 	62 (49.2%) 	16 (27.1%) 	
PRURITUS 	20 (37.7%) 	14 (19.2%) 	34 (27.0%) 	6 (10.2%) 	
Mild 	13 (24.5%) 	6 (8.2%) 	19 (15.1%) 	5 (8.5%) 	
Moderate 	7 (13.2%) 	7 (9.6%) 	14 (11.1%) 	1 (1.7%) 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ERYTHEMA 	12 (22.6%) 	8 (11.0%) 	20 (15.9%) 	6 (10.2%) 	
Mild 	8 (15.1%) 	3 (4.1%) 	11 (8.7%) 	2 (3.4%) 	
Moderate 	4 (7.5%) 	5 (6.8%) 	9 (7.1%) 	4 (6.8%) 	
 	 	 	 	 	
RASH 	5 (9.4%) 	9 (12.3%) 	14 (11.1%) 	4 (6.8%) 	
Mild 	4 (7.5%) 	5 (6.8%) 	9 (7.1%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	3 (5.1%) 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HYPERHIDROSIS 	8 (15.1%) 	4 (5.5%) 	12 (9.5%) 	2 (3.4%) 	
Mild 	8 (15.1%) 	1 (1.4%) 	9 (7.1%) 	2 (3.4%) 	
Moderate 	0 	3 (4.1%) 	3 (2.4%) 	0 	
 	 	 	 	 	
SKIN IRRITATION 	4 (7.5%) 	4 (5.5%) 	8 (6.3%) 	3 (5.1%) 	
Mild 	3 (5.7%) 	1 (1.4%) 	4 (3.2%) 	2 (3.4%) 	
Moderate 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	1 (1.7%) 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
BLISTER 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
RASH PRURITIC 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
URTICARIA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ACTINIC KERATOSIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PRURITUS GENERALISED 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
RASH ERYTHEMATOUS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
RASH MACULO-PAPULAR 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
SKIN ODOUR ABNORMAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
ALOPECIA 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
DRUG ERUPTION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
SKIN ULCER 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Nervous system disorders 	18 (34.0%) 	18 (24.7%) 	36 (28.6%) 	5 (8.5%) 	
DIZZINESS 	8 (15.1%) 	8 (11.0%) 	16 (12.7%) 	0 	
Mild 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	0 	
Moderate 	3 (5.7%) 	3 (4.1%) 	6 (4.8%) 	0 	
 	 	 	 	 	
HEADACHE 	5 (9.4%) 	3 (4.1%) 	8 (6.3%) 	2 (3.4%) 	
Mild 	4 (7.5%) 	2 (2.7%) 	6 (4.8%) 	2 (3.4%) 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
SYNCOPE 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
SOMNOLENCE 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
TRANSIENT ISCHAEMIC ATTACK 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
BALANCE DISORDER 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
BURNING SENSATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
COGNITIVE DISORDER 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
COMPLEX PARTIAL SEIZURES 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
COORDINATION ABNORMAL 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HEMIANOPIA HOMONYMOUS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HYPERSOMNIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
LETHARGY 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PARAESTHESIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PARAESTHESIA ORAL 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PAROSMIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PARTIAL SEIZURES WITH SECONDARY GENERALISATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Severe 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
STUPOR 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
SYNCOPE VASOVAGAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PARKINSON'S DISEASE 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
PSYCHOMOTOR HYPERACTIVITY 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Gastrointestinal disorders 	14 (26.4%) 	10 (13.7%) 	24 (19.0%) 	7 (11.9%) 	
NAUSEA 	5 (9.4%) 	2 (2.7%) 	7 (5.6%) 	0 	
Mild 	5 (9.4%) 	2 (2.7%) 	7 (5.6%) 	0 	
 	 	 	 	 	
VOMITING 	5 (9.4%) 	2 (2.7%) 	7 (5.6%) 	0 	
Mild 	4 (7.5%) 	1 (1.4%) 	5 (4.0%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
DIARRHOEA 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	3 (5.1%) 	
Mild 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	3 (5.1%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
SALIVARY HYPERSECRETION 	4 (7.5%) 	0 	4 (3.2%) 	0 	
Mild 	4 (7.5%) 	0 	4 (3.2%) 	0 	
 	 	 	 	 	
ABDOMINAL PAIN 	0 	2 (2.7%) 	2 (1.6%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ABDOMINAL DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DYSPEPSIA 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
RECTAL HAEMORRHAGE 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
STOMACH DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
CONSTIPATION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
GASTROOESOPHAGEAL REFLUX DISEASE 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
GLOSSITIS 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
HIATUS HERNIA 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Cardiac disorders 	11 (20.8%) 	11 (15.1%) 	22 (17.5%) 	7 (11.9%) 	
SINUS BRADYCARDIA 	7 (13.2%) 	4 (5.5%) 	11 (8.7%) 	0 	
Mild 	3 (5.7%) 	3 (4.1%) 	6 (4.8%) 	0 	
Moderate 	4 (7.5%) 	1 (1.4%) 	5 (4.0%) 	0 	
 	 	 	 	 	
MYOCARDIAL INFARCTION 	3 (5.7%) 	1 (1.4%) 	4 (3.2%) 	3 (5.1%) 	
Mild 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Severe 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
ATRIAL FIBRILLATION 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
VENTRICULAR EXTRASYSTOLES 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ATRIAL FLUTTER 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PALPITATIONS 	0 	2 (2.7%) 	2 (1.6%) 	0 	
Moderate 	0 	2 (2.7%) 	2 (1.6%) 	0 	
 	 	 	 	 	
ATRIOVENTRICULAR BLOCK FIRST DEGREE 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
BUNDLE BRANCH BLOCK RIGHT 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
CARDIAC DISORDER 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
SUPRAVENTRICULAR EXTRASYSTOLES 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
SUPRAVENTRICULAR TACHYCARDIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
WOLFF-PARKINSON-WHITE SYNDROME 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ATRIOVENTRICULAR BLOCK SECOND DEGREE 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
BUNDLE BRANCH BLOCK LEFT 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
SINUS ARRHYTHMIA 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
TACHYCARDIA 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Infections and infestations 	9 (17.0%) 	6 (8.2%) 	15 (11.9%) 	14 (23.7%) 	
NASOPHARYNGITIS 	3 (5.7%) 	3 (4.1%) 	6 (4.8%) 	2 (3.4%) 	
Mild 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
INFLUENZA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	
 	 	 	 	 	
UPPER RESPIRATORY TRACT INFECTION 	2 (3.8%) 	0 	2 (1.6%) 	5 (8.5%) 	
Mild 	2 (3.8%) 	0 	2 (1.6%) 	4 (6.8%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
CELLULITIS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HORDEOLUM 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
LOWER RESPIRATORY TRACT INFECTION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PNEUMONIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
RHINITIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
URINARY TRACT INFECTION 	1 (1.9%) 	0 	1 (0.8%) 	2 (3.4%) 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	2 (3.4%) 	
 	 	 	 	 	
BRONCHITIS 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
CERVICITIS 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
EAR INFECTION 	0 	0 	0 	2 (3.4%) 	
Mild 	0 	0 	0 	2 (3.4%) 	
 	 	 	 	 	
GASTROENTERITIS VIRAL 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
LOCALISED INFECTION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
VAGINAL MYCOSIS 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Psychiatric disorders 	6 (11.3%) 	8 (11.0%) 	14 (11.1%) 	7 (11.9%) 	
CONFUSIONAL STATE 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	2 (3.4%) 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Moderate 	0 	3 (4.1%) 	3 (2.4%) 	1 (1.7%) 	
 	 	 	 	 	
AGITATION 	0 	2 (2.7%) 	2 (1.6%) 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ANXIETY 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
DELIRIUM 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DELUSION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DEPRESSED MOOD 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HALLUCINATION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
HALLUCINATION, VISUAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
INSOMNIA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
IRRITABILITY 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
LIBIDO DECREASED 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
LISTLESS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
NIGHTMARE 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
RESTLESSNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
DISORIENTATION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
DISTURBANCE IN SEXUAL AROUSAL 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Respiratory, thoracic and mediastinal disorders 	7 (13.2%) 	6 (8.2%) 	13 (10.3%) 	5 (8.5%) 	
COUGH 	3 (5.7%) 	4 (5.5%) 	7 (5.6%) 	1 (1.7%) 	
Mild 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
NASAL CONGESTION 	3 (5.7%) 	0 	3 (2.4%) 	2 (3.4%) 	
Mild 	3 (5.7%) 	0 	3 (2.4%) 	2 (3.4%) 	
 	 	 	 	 	
EPISTAXIS 	2 (3.8%) 	0 	2 (1.6%) 	0 	
Mild 	2 (3.8%) 	0 	2 (1.6%) 	0 	
 	 	 	 	 	
RHINORRHOEA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
ALLERGIC GRANULOMATOUS ANGIITIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DYSPHONIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
DYSPNOEA 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PHARYNGOLARYNGEAL PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
PRODUCTIVE COUGH 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
RESPIRATORY TRACT CONGESTION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
EMPHYSEMA 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
POSTNASAL DRIP 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Investigations 	5 (9.4%) 	7 (9.6%) 	12 (9.5%) 	7 (11.9%) 	
BLOOD GLUCOSE INCREASED 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
ELECTROCARDIOGRAM T WAVE INVERSION 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	
 	 	 	 	 	
BIOPSY 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
BIOPSY PROSTATE 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
BLOOD CHOLESTEROL INCREASED 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
BODY TEMPERATURE INCREASED 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 	0 	1 (1.4%) 	1 (0.8%) 	3 (5.1%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	3 (5.1%) 	
 	 	 	 	 	
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
NASAL MUCOSA BIOPSY 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
WEIGHT DECREASED 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
BLOOD ALKALINE PHOSPHATASE INCREASED 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
BLOOD CREATINE PHOSPHOKINASE INCREASED 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
BLOOD URINE PRESENT 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
CYSTOSCOPY 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Musculoskeletal and connective tissue disorders 	4 (7.5%) 	5 (6.8%) 	9 (7.1%) 	2 (3.4%) 	
BACK PAIN 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
ARTHRALGIA 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
FLANK PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
MUSCLE SPASMS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
MUSCULAR WEAKNESS 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
MYALGIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
SHOULDER PAIN 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Injury, poisoning and procedural complications 	3 (5.7%) 	5 (6.8%) 	8 (6.3%) 	2 (3.4%) 	
CONTUSION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	
Mild 	2 (3.8%) 	0 	2 (1.6%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
FALL 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
EXCORIATION 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
SKIN LACERATION 	0 	2 (2.7%) 	2 (1.6%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
FACIAL BONES FRACTURE 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
JOINT DISLOCATION 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
WOUND 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HIP FRACTURE 	0 	0 	0 	1 (1.7%) 	
Severe 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Renal and urinary disorders 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	2 (3.4%) 	
CALCULUS URETHRAL 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DYSURIA 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
INCONTINENCE 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
MICTURITION URGENCY 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
NEPHROLITHIASIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
Vascular disorders 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	3 (5.1%) 	
HOT FLUSH 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
HYPERTENSION 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
HYPOTENSION 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
WOUND HAEMORRHAGE 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
ORTHOSTATIC HYPOTENSION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Ear and labyrinth disorders 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	1 (1.7%) 	
VERTIGO 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Moderate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
 	 	 	 	 	
CERUMEN IMPACTION 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
EAR PAIN 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Eye disorders 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	2 (3.4%) 	
VISION BLURRED 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
CONJUNCTIVAL HAEMORRHAGE 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
CONJUNCTIVITIS 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
EYE ALLERGY 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
EYE PRURITUS 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
EYE SWELLING 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Reproductive system and breast disorders 	3 (5.7%) 	0 	3 (2.4%) 	3 (5.1%) 	
ABNORMAL UTERINE BLEEDING 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
BENIGN PROSTATIC HYPERPLASIA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Moderate 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Severe 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
ERECTILE DYSFUNCTION 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
PELVIC PAIN 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Congenital, familial and genetic disorders 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
VENTRICULAR SEPTAL DEFECT 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Moderate 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	
COLON CANCER 	0 	1 (1.4%) 	1 (0.8%) 	0 	
Severe 	0 	1 (1.4%) 	1 (0.8%) 	0 	
 	 	 	 	 	
PROSTATE CANCER 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Severe 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
Endocrine disorders 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
BLEEDING ANOVULATORY 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
Mild 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	
 	 	 	 	 	
Metabolism and nutrition disorders 	1 (1.9%) 	0 	1 (0.8%) 	2 (3.4%) 	
INCREASED APPETITE 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
DECREASED APPETITE 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
DEHYDRATION 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
Surgical and medical procedures 	1 (1.9%) 	0 	1 (0.8%) 	2 (3.4%) 	
ACROCHORDON EXCISION 	1 (1.9%) 	0 	1 (0.8%) 	0 	
Mild 	1 (1.9%) 	0 	1 (0.8%) 	0 	
 	 	 	 	 	
CATARACT OPERATION 	0 	0 	0 	1 (1.7%) 	
Moderate 	0 	0 	0 	1 (1.7%) 	
 	 	 	 	 	
EYE LASER SURGERY 	0 	0 	0 	1 (1.7%) 	
Mild 	0 	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. The event experienced by the subject with the worst severity is used. 	
Note:  Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. The event experienced by the subject with the worst severity is used.	
Note:  Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. The event experienced by the subject with the worst severity is used.	
Note:  Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. The event experienced by the subject with the worst severity is used.	
Note:  Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. The event experienced by the subject with the worst severity is used.	
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.