TSFAE13:	Exposure-adjusted Incidence Rate Analysis by Preferred Term; Safety Analysis Set (Study jjcs - core)						
 	Active Study Agent 	Active Study Agent 	 	Risk Difference (95% CI) 	Risk Difference (95% CI) 	
 	Xanomeline High Dose 	Xanomeline Low Dose 	Placebo 	Xanomeline High Dose vs Placebo 	Xanomeline Low Dose vs Placebo 	
Preferred Term, EAIR Per 100 SY 	N=53 	N=73 	N=59 	  	  	
Subject yearsᵃ 	92.1 	126.5 	99.8 	 	 	
 	 	 	 	 	 	
PRURITUS 	30.4 	13.9 	6.7 	23.77 (9.41, 38.12) 	7.28 (-1.75, 16.31) 	
APPLICATION SITE PRURITUS 	18.4 	16.3 	4.2 	14.18 (3.39, 24.97) 	12.09 (3.34, 20.84) 	
ERYTHEMA 	16.0 	7.3 	6.6 	9.31 (-1.16, 19.79) 	0.68 (-6.67, 8.02) 	
APPLICATION SITE ERYTHEMA 	13.1 	10.0 	2.1 	11.06 (2.43, 19.68) 	7.96 (1.38, 14.55) 	
HYPERHIDROSIS 	10.7 	3.3 	2.1 	8.62 (0.67, 16.56) 	1.19 (-3.11, 5.49) 	
APPLICATION SITE IRRITATION 	10.3 	6.2 	2.1 	8.21 (0.55, 15.87) 	4.11 (-1.27, 9.50) 	
DIZZINESS 	9.1 	6.9 	0.0 	9.08 (2.35, 15.80) 	6.88 (2.11, 11.65) 	
SINUS BRADYCARDIA 	8.7 	3.3 	0.0 	8.66 (2.24, 15.07) 	3.35 (0.07, 6.63) 	
HEADACHE 	6.2 	2.5 	2.1 	4.12 (-2.00, 10.24) 	0.40 (-3.58, 4.38) 	
VOMITING 	6.1 	1.6 	0.0 	6.12 (0.76, 11.48) 	1.60 (-0.62, 3.81) 	
RASH 	6.0 	8.1 	4.3 	1.70 (-4.99, 8.39) 	3.86 (-2.90, 10.61) 	
FATIGUE 	5.9 	4.3 	0.0 	5.93 (0.73, 11.12) 	4.30 (0.53, 8.07) 	
NAUSEA 	5.8 	1.7 	0.0 	5.84 (0.72, 10.97) 	1.65 (-0.64, 3.94) 	
SKIN IRRITATION 	4.7 	3.3 	3.1 	1.67 (-4.12, 7.47) 	0.28 (-4.49, 5.05) 	
APPLICATION SITE DERMATITIS 	4.7 	6.0 	5.5 	-0.77 (-7.42, 5.89) 	0.57 (-5.99, 7.13) 	
APPLICATION SITE VESICLES 	4.6 	3.3 	0.0 	4.58 (0.09, 9.07) 	3.31 (0.07, 6.55) 	
SALIVARY HYPERSECRETION 	4.4 	0.0 	0.0 	4.42 (0.09, 8.76) 	0.00 (0.00, 0.00) 	
NASAL CONGESTION 	3.5 	0.0 	2.0 	1.44 (-3.40, 6.28) 	-2.04 (-4.86, 0.79) 	
MYOCARDIAL INFARCTION 	3.4 	0.8 	3.1 	0.30 (-4.94, 5.55) 	-2.33 (-6.19, 1.53) 	
COUGH 	3.4 	3.4 	1.0 	2.38 (-1.94, 6.71) 	2.35 (-1.49, 6.20) 	
NASOPHARYNGITIS 	3.4 	2.5 	2.1 	1.24 (-3.59, 6.07) 	0.36 (-3.73, 4.44) 	
MALAISE 	2.3 	0.8 	0.0 	2.32 (-0.90, 5.55) 	0.81 (-0.77, 2.38) 	
RASH PRURITIC 	2.3 	0.8 	0.0 	2.32 (-0.89, 5.53) 	0.80 (-0.77, 2.37) 	
APPLICATION SITE PERSPIRATION 	2.3 	0.0 	0.0 	2.31 (-0.89, 5.51) 	0.00 (0.00, 0.00) 	
BACK PAIN 	2.3 	0.8 	1.0 	1.28 (-2.45, 5.02) 	-0.20 (-2.72, 2.33) 	
DIARRHOEA 	2.3 	2.4 	3.1 	-0.82 (-5.55, 3.90) 	-0.66 (-5.13, 3.80) 	
CONTUSION 	2.3 	0.8 	0.0 	2.27 (-0.87, 5.40) 	0.80 (-0.77, 2.36) 	
EPISTAXIS 	2.3 	0.0 	0.0 	2.26 (-0.87, 5.40) 	0.00 (0.00, 0.00) 	
UPPER RESPIRATORY TRACT INFECTION 	2.3 	0.0 	5.3 	-3.01 (-8.59, 2.58) 	-5.27 (-9.89, -0.65) 	
APPLICATION SITE PAIN 	2.3 	0.0 	0.0 	2.26 (-0.87, 5.38) 	0.00 (0.00, 0.00) 	
APPLICATION SITE SWELLING 	2.2 	0.8 	0.0 	2.25 (-0.87, 5.37) 	0.80 (-0.77, 2.36) 	
CHEST PAIN 	2.2 	0.0 	0.0 	2.22 (-0.86, 5.30) 	0.00 (0.00, 0.00) 	
DELIRIUM 	1.1 	0.0 	0.0 	1.13 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
STOMACH DISCOMFORT 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
PAIN 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
URTICARIA 	1.1 	0.8 	0.0 	1.12 (-1.08, 3.33) 	0.81 (-0.77, 2.39) 	
MYALGIA 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
PHARYNGOLARYNGEAL PAIN 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
PRODUCTIVE COUGH 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.33) 	0.00 (0.00, 0.00) 	
ABDOMINAL DISCOMFORT 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
RESPIRATORY TRACT CONGESTION 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
RHINITIS 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
FEELING ABNORMAL 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
LIBIDO DECREASED 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
LISTLESS 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
VISION BLURRED 	1.1 	0.8 	0.0 	1.12 (-1.08, 3.32) 	0.79 (-0.76, 2.35) 	
COGNITIVE DISORDER 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
INCREASED APPETITE 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
CHILLS 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
ABNORMAL UTERINE BLEEDING 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
CONFUSIONAL STATE 	1.1 	2.5 	2.1 	-0.93 (-4.53, 2.66) 	0.42 (-3.57, 4.41) 	
INSOMNIA 	1.1 	0.0 	1.0 	0.11 (-2.84, 3.07) 	-1.01 (-2.99, 0.97) 	
SOMNOLENCE 	1.1 	1.6 	1.0 	0.09 (-2.89, 3.07) 	0.58 (-2.43, 3.60) 	
PRURITUS GENERALISED 	1.1 	0.0 	0.0 	1.12 (-1.08, 3.32) 	0.00 (0.00, 0.00) 	
BURNING SENSATION 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.31) 	0.00 (0.00, 0.00) 	
VENTRICULAR EXTRASYSTOLES 	1.1 	1.6 	0.0 	1.12 (-1.07, 3.31) 	1.64 (-0.63, 3.91) 	
NIGHTMARE 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.31) 	0.00 (0.00, 0.00) 	
BIOPSY 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.31) 	0.00 (0.00, 0.00) 	
BLOOD CHOLESTEROL INCREASED 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.31) 	0.00 (0.00, 0.00) 	
ALLERGIC GRANULOMATOUS ANGIITIS 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.31) 	0.00 (0.00, 0.00) 	
FEELING COLD 	1.1 	0.0 	0.0 	1.12 (-1.07, 3.30) 	0.00 (0.00, 0.00) 	
OEDEMA PERIPHERAL 	1.1 	0.8 	1.0 	0.10 (-2.86, 3.06) 	-0.23 (-2.76, 2.30) 	
CHEST DISCOMFORT 	1.1 	0.8 	0.0 	1.11 (-1.07, 3.30) 	0.79 (-0.76, 2.35) 	
WOUND HAEMORRHAGE 	1.1 	0.0 	0.0 	1.11 (-1.07, 3.30) 	0.00 (0.00, 0.00) 	
HALLUCINATION, VISUAL 	1.1 	0.0 	0.0 	1.11 (-1.07, 3.29) 	0.00 (0.00, 0.00) 	
PARTIAL SEIZURES WITH SECONDARY GENERALISATION 	1.1 	0.0 	0.0 	1.11 (-1.07, 3.29) 	0.00 (0.00, 0.00) 	
BIOPSY PROSTATE 	1.1 	0.0 	0.0 	1.11 (-1.07, 3.29) 	0.00 (0.00, 0.00) 	
BENIGN PROSTATIC HYPERPLASIA 	1.1 	0.0 	1.0 	0.08 (-2.88, 3.05) 	-1.03 (-3.04, 0.98) 	
ELECTROCARDIOGRAM T WAVE INVERSION 	1.1 	0.8 	2.1 	-0.97 (-4.57, 2.63) 	-1.28 (-4.55, 1.99) 	
VERTIGO 	1.1 	0.8 	0.0 	1.10 (-1.06, 3.27) 	0.80 (-0.77, 2.38) 	
SKIN ODOUR ABNORMAL 	1.1 	0.0 	0.0 	1.10 (-1.06, 3.26) 	0.00 (0.00, 0.00) 	
TRANSIENT ISCHAEMIC ATTACK 	1.1 	1.6 	0.0 	1.10 (-1.06, 3.26) 	1.60 (-0.62, 3.81) 	
ARTHRALGIA 	1.1 	0.8 	0.0 	1.10 (-1.06, 3.26) 	0.80 (-0.77, 2.37) 	
VENTRICULAR SEPTAL DEFECT 	1.1 	0.8 	0.0 	1.10 (-1.06, 3.26) 	0.81 (-0.77, 2.39) 	
HORDEOLUM 	1.1 	0.0 	0.0 	1.10 (-1.06, 3.25) 	0.00 (0.00, 0.00) 	
SYNCOPE VASOVAGAL 	1.1 	0.0 	0.0 	1.10 (-1.06, 3.25) 	0.00 (0.00, 0.00) 	
CARDIAC DISORDER 	1.1 	0.0 	0.0 	1.10 (-1.06, 3.25) 	0.00 (0.00, 0.00) 	
INFLUENZA 	1.1 	0.8 	1.0 	0.08 (-2.87, 3.02) 	-0.21 (-2.77, 2.34) 	
NEPHROLITHIASIS 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.25) 	0.00 (0.00, 0.00) 	
URINARY TRACT INFECTION 	1.1 	0.0 	2.1 	-0.99 (-4.60, 2.62) 	-2.09 (-4.99, 0.81) 	
LOWER RESPIRATORY TRACT INFECTION 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.25) 	0.00 (0.00, 0.00) 	
ACROCHORDON EXCISION 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
FLANK PAIN 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
HYPERSOMNIA 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
CALCULUS URETHRAL 	1.1 	0.0 	0.0 	1.10 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
SYNCOPE 	1.1 	2.4 	0.0 	1.09 (-1.05, 3.24) 	2.42 (-0.32, 5.17) 	
FACIAL BONES FRACTURE 	1.1 	0.0 	0.0 	1.09 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
FALL 	1.1 	1.6 	1.0 	0.09 (-2.83, 3.00) 	0.60 (-2.38, 3.58) 	
ACTINIC KERATOSIS 	1.1 	0.0 	0.0 	1.09 (-1.05, 3.24) 	0.00 (0.00, 0.00) 	
APPLICATION SITE REACTION 	1.1 	0.0 	1.0 	0.06 (-2.88, 3.01) 	-1.03 (-3.05, 0.99) 	
ERECTILE DYSFUNCTION 	1.1 	0.0 	1.0 	0.07 (-2.86, 3.00) 	-1.02 (-3.02, 0.98) 	
ATRIAL FLUTTER 	1.1 	0.8 	0.0 	1.09 (-1.05, 3.23) 	0.81 (-0.77, 2.39) 	
ATRIAL FIBRILLATION 	1.1 	1.6 	0.0 	1.09 (-1.05, 3.23) 	1.63 (-0.63, 3.90) 	
EXCORIATION 	1.1 	0.8 	0.0 	1.09 (-1.05, 3.23) 	0.81 (-0.78, 2.39) 	
BLISTER 	1.1 	1.6 	0.0 	1.09 (-1.05, 3.23) 	1.62 (-0.62, 3.86) 	
PARAESTHESIA 	1.1 	0.0 	0.0 	1.09 (-1.05, 3.23) 	0.00 (0.00, 0.00) 	
DELUSION 	1.1 	0.0 	1.0 	0.08 (-2.84, 2.99) 	-1.01 (-2.99, 0.97) 	
HALLUCINATION 	1.1 	0.0 	0.0 	1.09 (-1.05, 3.22) 	0.00 (0.00, 0.00) 	
BLOOD GLUCOSE INCREASED 	1.1 	0.8 	0.0 	1.09 (-1.05, 3.22) 	0.80 (-0.77, 2.37) 	
PROSTATE CANCER 	1.1 	0.0 	0.0 	1.09 (-1.04, 3.22) 	0.00 (0.00, 0.00) 	
PAROSMIA 	1.1 	0.0 	0.0 	1.09 (-1.04, 3.21) 	0.00 (0.00, 0.00) 	
RHINORRHOEA 	1.1 	0.8 	0.0 	1.08 (-1.04, 3.20) 	0.81 (-0.78, 2.39) 	
ABDOMINAL PAIN 	0.0 	1.6 	1.0 	-1.03 (-3.04, 0.98) 	0.58 (-2.42, 3.57) 	
AGITATION 	0.0 	1.6 	1.0 	-1.01 (-2.98, 0.97) 	0.59 (-2.38, 3.56) 	
ALOPECIA 	0.0 	0.0 	1.0 	-1.00 (-2.97, 0.96) 	-1.00 (-2.97, 0.96) 	
ANXIETY 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.39) 	
APPLICATION SITE BLEEDING 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.36) 	
APPLICATION SITE DESQUAMATION 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.36) 	
APPLICATION SITE INDURATION 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
APPLICATION SITE URTICARIA 	0.0 	1.6 	0.0 	0.00 (0.00, 0.00) 	1.64 (-0.63, 3.91) 	
ASTHENIA 	0.0 	0.8 	1.0 	-1.03 (-3.06, 0.99) 	-0.23 (-2.79, 2.33) 	
ATRIOVENTRICULAR BLOCK FIRST DEGREE 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.77, 2.39) 	
ATRIOVENTRICULAR BLOCK SECOND DEGREE 	0.0 	0.0 	1.0 	-1.02 (-3.02, 0.98) 	-1.02 (-3.02, 0.98) 	
BALANCE DISORDER 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.36) 	
BLEEDING ANOVULATORY 	0.0 	0.8 	1.0 	-1.01 (-2.98, 0.97) 	-0.21 (-2.73, 2.31) 	
BLOOD ALKALINE PHOSPHATASE INCREASED 	0.0 	0.0 	1.0 	-1.01 (-3.00, 0.97) 	-1.01 (-3.00, 0.97) 	
BLOOD CREATINE PHOSPHOKINASE INCREASED 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
BLOOD URINE PRESENT 	0.0 	0.0 	1.0 	-1.03 (-3.04, 0.98) 	-1.03 (-3.04, 0.98) 	
BODY TEMPERATURE INCREASED 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.36) 	
BRONCHITIS 	0.0 	0.0 	1.0 	-1.02 (-3.00, 0.97) 	-1.02 (-3.00, 0.97) 	
BUNDLE BRANCH BLOCK LEFT 	0.0 	0.0 	1.0 	-1.00 (-2.97, 0.96) 	-1.00 (-2.97, 0.96) 	
BUNDLE BRANCH BLOCK RIGHT 	0.0 	0.8 	1.0 	-1.02 (-3.01, 0.98) 	-0.21 (-2.75, 2.33) 	
CATARACT OPERATION 	0.0 	0.0 	1.0 	-1.02 (-3.03, 0.98) 	-1.02 (-3.03, 0.98) 	
CELLULITIS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
CERUMEN IMPACTION 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
CERVICITIS 	0.0 	0.0 	1.0 	-1.03 (-3.05, 0.99) 	-1.03 (-3.05, 0.99) 	
COLON CANCER 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.79 (-0.76, 2.35) 	
COMPLEX PARTIAL SEIZURES 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.36) 	
CONJUNCTIVAL HAEMORRHAGE 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
CONJUNCTIVITIS 	0.0 	0.0 	1.0 	-1.01 (-2.98, 0.97) 	-1.01 (-2.98, 0.97) 	
CONSTIPATION 	0.0 	0.0 	1.0 	-1.03 (-3.04, 0.98) 	-1.03 (-3.04, 0.98) 	
COORDINATION ABNORMAL 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.36) 	
CYSTOSCOPY 	0.0 	0.0 	1.0 	-1.03 (-3.04, 0.98) 	-1.03 (-3.04, 0.98) 	
DECREASED APPETITE 	0.0 	0.0 	1.0 	-1.02 (-3.02, 0.98) 	-1.02 (-3.02, 0.98) 	
DEHYDRATION 	0.0 	0.0 	1.0 	-1.02 (-3.03, 0.98) 	-1.02 (-3.03, 0.98) 	
DEPRESSED MOOD 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
DISORIENTATION 	0.0 	0.0 	1.0 	-1.02 (-3.02, 0.98) 	-1.02 (-3.02, 0.98) 	
DISTURBANCE IN SEXUAL AROUSAL 	0.0 	0.0 	1.0 	-1.00 (-2.96, 0.96) 	-1.00 (-2.96, 0.96) 	
DRUG ERUPTION 	0.0 	0.0 	1.0 	-1.01 (-2.98, 0.97) 	-1.01 (-2.98, 0.97) 	
DYSPEPSIA 	0.0 	0.8 	1.0 	-1.03 (-3.06, 0.99) 	-0.22 (-2.80, 2.36) 	
DYSPHONIA 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
DYSPNOEA 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
DYSURIA 	0.0 	0.8 	1.0 	-1.03 (-3.06, 0.99) 	-0.24 (-2.79, 2.30) 	
EAR INFECTION 	0.0 	0.0 	2.0 	-2.05 (-4.89, 0.79) 	-2.05 (-4.89, 0.79) 	
EAR PAIN 	0.0 	0.0 	1.0 	-1.01 (-3.00, 0.97) 	-1.01 (-3.00, 0.97) 	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 	0.0 	0.8 	3.1 	-3.11 (-6.62, 0.41) 	-2.30 (-6.16, 1.55) 	
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 	0.0 	0.8 	1.0 	-1.02 (-3.02, 0.98) 	-0.21 (-2.76, 2.33) 	
EMPHYSEMA 	0.0 	0.0 	1.0 	-1.03 (-3.04, 0.99) 	-1.03 (-3.04, 0.99) 	
EYE ALLERGY 	0.0 	0.0 	1.0 	-1.01 (-3.00, 0.97) 	-1.01 (-3.00, 0.97) 	
EYE LASER SURGERY 	0.0 	0.0 	1.0 	-1.03 (-3.06, 0.99) 	-1.03 (-3.06, 0.99) 	
EYE PRURITUS 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
EYE SWELLING 	0.0 	0.0 	1.0 	-1.01 (-3.00, 0.97) 	-1.01 (-3.00, 0.97) 	
GASTROENTERITIS VIRAL 	0.0 	0.0 	1.0 	-1.03 (-3.06, 0.99) 	-1.03 (-3.06, 0.99) 	
GASTROOESOPHAGEAL REFLUX DISEASE 	0.0 	0.0 	1.0 	-1.03 (-3.06, 0.99) 	-1.03 (-3.06, 0.99) 	
GLOSSITIS 	0.0 	0.0 	1.0 	-1.01 (-2.98, 0.97) 	-1.01 (-2.98, 0.97) 	
HEMIANOPIA HOMONYMOUS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.39) 	
HIATUS HERNIA 	0.0 	0.0 	1.0 	-1.00 (-2.97, 0.96) 	-1.00 (-2.97, 0.96) 	
HIP FRACTURE 	0.0 	0.0 	1.0 	-1.01 (-3.00, 0.97) 	-1.01 (-3.00, 0.97) 	
HOT FLUSH 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.40) 	
HYPERTENSION 	0.0 	0.8 	1.0 	-1.03 (-3.04, 0.99) 	-0.23 (-2.78, 2.32) 	
HYPOTENSION 	0.0 	0.8 	2.1 	-2.07 (-4.93, 0.80) 	-1.26 (-4.53, 2.00) 	
INCONTINENCE 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.38) 	
IRRITABILITY 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.39) 	
JOINT DISLOCATION 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.38) 	
LETHARGY 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.38) 	
LOCALISED INFECTION 	0.0 	0.0 	1.0 	-1.03 (-3.04, 0.99) 	-1.03 (-3.04, 0.99) 	
MICTURITION URGENCY 	0.0 	0.8 	1.0 	-1.02 (-3.03, 0.98) 	-0.22 (-2.77, 2.32) 	
MUSCLE SPASMS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.40) 	
MUSCULAR WEAKNESS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
NASAL MUCOSA BIOPSY 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
OEDEMA 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.78, 2.40) 	
ORTHOSTATIC HYPOTENSION 	0.0 	0.0 	1.0 	-1.02 (-3.03, 0.98) 	-1.02 (-3.03, 0.98) 	
PALPITATIONS 	0.0 	1.6 	0.0 	0.00 (0.00, 0.00) 	1.62 (-0.62, 3.86) 	
PARAESTHESIA ORAL 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
PARKINSON'S DISEASE 	0.0 	0.0 	1.0 	-1.03 (-3.05, 0.99) 	-1.03 (-3.05, 0.99) 	
PELVIC PAIN 	0.0 	0.0 	1.0 	-1.03 (-3.06, 0.99) 	-1.03 (-3.06, 0.99) 	
PNEUMONIA 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
POSTNASAL DRIP 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
PSYCHOMOTOR HYPERACTIVITY 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
PYREXIA 	0.0 	0.8 	2.1 	-2.07 (-4.95, 0.80) 	-1.27 (-4.55, 2.01) 	
RASH ERYTHEMATOUS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.36) 	
RECTAL HAEMORRHAGE 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
RESTLESSNESS 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.38) 	
SECRETION DISCHARGE 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
SHOULDER PAIN 	0.0 	0.8 	1.0 	-1.01 (-2.99, 0.97) 	-0.21 (-2.74, 2.32) 	
SINUS ARRHYTHMIA 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
SKIN LACERATION 	0.0 	1.6 	0.0 	0.00 (0.00, 0.00) 	1.62 (-0.62, 3.86) 	
SKIN ULCER 	0.0 	0.0 	1.0 	-1.03 (-3.06, 0.99) 	-1.03 (-3.06, 0.99) 	
STUPOR 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.79 (-0.76, 2.35) 	
SUDDEN DEATH 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.37) 	
SUPRAVENTRICULAR EXTRASYSTOLES 	0.0 	0.8 	1.0 	-1.02 (-3.01, 0.98) 	-0.22 (-2.75, 2.32) 	
SUPRAVENTRICULAR TACHYCARDIA 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.77, 2.39) 	
TACHYCARDIA 	0.0 	0.0 	1.0 	-1.01 (-2.99, 0.97) 	-1.01 (-2.99, 0.97) 	
ULCER 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.76, 2.35) 	
VAGINAL MYCOSIS 	0.0 	0.0 	1.0 	-1.03 (-3.05, 0.99) 	-1.03 (-3.05, 0.99) 	
WEIGHT DECREASED 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.79 (-0.76, 2.35) 	
WOLFF-PARKINSON-WHITE SYNDROME 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.80 (-0.77, 2.38) 	
WOUND 	0.0 	0.8 	0.0 	0.00 (0.00, 0.00) 	0.81 (-0.77, 2.39) 	

Key: EAIR=exposure-adjusted incidence rate, SY=subject years 	
Key: EAIR=exposure-adjusted incidence rate, SY=subject years	
Key: EAIR=exposure-adjusted incidence rate, SY=subject years	
Key: EAIR=exposure-adjusted incidence rate, SY=subject years	
Key: EAIR=exposure-adjusted incidence rate, SY=subject years	
Key: EAIR=exposure-adjusted incidence rate, SY=subject years	
a Subject years is the sum of all exposures per treatment group. 	a Subject years is the sum of all exposures per treatment group.	a Subject years is the sum of all exposures per treatment group.	a Subject years is the sum of all exposures per treatment group.	a Subject years is the sum of all exposures per treatment group.	a Subject years is the sum of all exposures per treatment group.	
Note: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date]. 	: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].	: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].	: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].	: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].	: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].	
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.