TSICM02:	Concomitant Medications; Safety Analysis Set (Study jjcs - core)						
 	Active Study Agent 	Active Study Agent 	Active Study Agent 	 	 	
ATC Level 1 	Xanomeline High Dose 	Xanomeline Low Dose 	Combined 	Placebo 	Total 	
  Base Preferred Term 	N=53 	N=73 	N=126 	N=59 	N=185 	
Subjects with ≥1 concomitant medication 	38 (71.7%) 	43 (58.9%) 	81 (64.3%) 	35 (59.3%) 	116 (62.7%) 	
 	 	 	 	 	 	
Uncoded 	34 (64.2%) 	35 (47.9%) 	69 (54.8%) 	34 (57.6%) 	103 (55.7%) 	
Uncoded: hydrocortisone, topical 	11 (20.8%) 	12 (16.4%) 	23 (18.3%) 	4 (6.8%) 	27 (14.6%) 	
Uncoded: cortisone 	8 (15.1%) 	4 (5.5%) 	12 (9.5%) 	4 (6.8%) 	16 (8.6%) 	
Uncoded: benadryl 	7 (13.2%) 	6 (8.2%) 	13 (10.3%) 	1 (1.7%) 	14 (7.6%) 	
Uncoded: ativan 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	2 (3.4%) 	6 (3.2%) 	
Uncoded: claritin 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	1 (1.7%) 	5 (2.7%) 	
Uncoded: lorazepam 	1 (1.9%) 	4 (5.5%) 	5 (4.0%) 	0 	5 (2.7%) 	
Uncoded: calamine lotion 	3 (5.7%) 	1 (1.4%) 	4 (3.2%) 	0 	4 (2.2%) 	
Uncoded: lidex 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	0 	4 (2.2%) 	
Uncoded: motrin 	0 	1 (1.4%) 	1 (0.8%) 	3 (5.1%) 	4 (2.2%) 	
Uncoded: robitussin 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	2 (3.4%) 	4 (2.2%) 	
Uncoded: advil 	2 (3.8%) 	0 	2 (1.6%) 	1 (1.7%) 	3 (1.6%) 	
Uncoded: robitussin-dm 	0 	1 (1.4%) 	1 (0.8%) 	2 (3.4%) 	3 (1.6%) 	
Uncoded: allegra 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: bactrim 	0 	0 	0 	2 (3.4%) 	2 (1.1%) 	
Uncoded: erythromycin 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: ibuprofen 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: multivitamin 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: neosporin /usa/ 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: prilosec 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: sudafed 	0 	0 	0 	2 (3.4%) 	2 (1.1%) 	
Uncoded: sulfamethoxazole 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: tylenol 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: vitamin c 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: vitamin e 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Uncoded: acetaminophen 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: albuterol 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: aloe vera 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: amoxicillin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: antihistamines for systemic use 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: armour thyroid 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: augmentin 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: beconase 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: biaxin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: bromatane dx 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: cefaclor 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: ceftin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: cephalexin 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: cephalosporin c 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: chloral hydrate 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: cimetidine 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: cipro 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: coricidin d 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: corticosteroids, dermatological preparations 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: dalmane 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: demerol 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: diabeta 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: diltiazem hydrochloride 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: diphenhydramine hydrochloride 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: diprolene cream 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: donepezil hydrochloride 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: doxycycline 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: droperidol 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: estrace 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: fluocinolone acetonide 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: fluoroplex 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: furosemide 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: general anesthesia 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: glyburide 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: guiatuss 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: halotussin-dm 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: herbal preparation 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: hydrocodone 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: hydrocodone w/apap 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: hydrocortisone valerate 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: icy hot 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: influenza virus vaccine 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: keflex 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: kenalog 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: lac-hydrin 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: lansoprazole 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: lipitor 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: lomotil 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: magnesium oxide 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: mavik 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: maxzide 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: melatonin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: metamucil 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: metronidazole 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: mevacor 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: monopril 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: mylanta 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: naproxen 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: neo-synephrine 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: olanzapine 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: pepcid 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: persantine 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: pertussin syrup 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: phenazopyridine 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: phenergan 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: pilocarpine hydrochloride 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: pneumovax 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: polysporin 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: polysporin ointment 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: potassium chloride 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: prednisone 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: premarin vaginal cream 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: prempro 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: preparation h 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: promethazine hcl w/codeine 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: propulsid 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: pseudoephedrine hydrochloride 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: rocephin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: sinemet 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: sulfacetamide 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: terazol 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: topicort 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: toradol 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: triamcinolone 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: trimox 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: tums 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: tylenol extra strength 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: tylenol sinus 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: tylenol w/codeine no. 3 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: vicks formula 44d 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: vitamin b12 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: westcort 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: zantac 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Uncoded: zithromax 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Uncoded: zocor 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
 	 	 	 	 	 	
Systemic hormonal preparations, excl. 	7 (13.2%) 	9 (12.3%) 	16 (12.7%) 	1 (1.7%) 	17 (9.2%) 	
Hydrocortisone 	7 (13.2%) 	9 (12.3%) 	16 (12.7%) 	1 (1.7%) 	17 (9.2%) 	
 	 	 	 	 	 	
Nervous system 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	2 (3.4%) 	6 (3.2%) 	
Donepezil hydrochloride 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	3 (1.6%) 	
Acetylsalicylic acid 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Haloperidol 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Paroxetine hydrochloride 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
 	 	 	 	 	 	
Cardiovascular system 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	0 	4 (2.2%) 	
Doxazosin mesilate 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	2 (1.1%) 	
Digoxin 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Losartan potassium 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
 	 	 	 	 	 	
Alimentary tract and metabolism 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	2 (1.1%) 	
Cimetidine 	0 	1 (1.4%) 	1 (0.8%) 	0 	1 (0.5%) 	
Loperamide hydrochloride 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
 	 	 	 	 	 	
Dermatologicals 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
Clobetasol propionate 	1 (1.9%) 	0 	1 (0.8%) 	0 	1 (0.5%) 	
 	 	 	 	 	 	
Respiratory system 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	
Guaifenesin 	0 	0 	0 	1 (1.7%) 	1 (0.5%) 	

Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment. 	
Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment.	
Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment.	
Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment.	
Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment.	
Note: Concomitant medications are defined as any therapy used on or after the same day as the first dose of study treatment [up to last dose of study treatment +xx days], including those that started before and continue on after the first dose of study treatment.