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. 2018 Mar 2;8(3):e021000. doi: 10.1136/bmjopen-2017-021000

Table 1.

Schedule of visits and assessments

Visit 0 1 2 3 4 5 6 7 8 9
Screening Baseline
Week 0 2 3 4 8 12 16 20 24
Study medication period (24 weeks)
Screening and consent
 Assessment of current medication x x x x x x x x x x
 Informed consent x
 Ongoing capacity x x x x x x x x x x
 Inclusion/exclusion criteria x
 Beta-HCG (females only) x
 Drug dispensation (after randomisation) x x x x x x x x x
Safety
 Adverse events x x x x x x x x
 SAFTEE-SI x x x x x x x x x
 Vitamin B12 x x x
Efficacy
 Height x x
 Body weight x x x x x x x x x x
 Waist circumference and hip/waist ratio x x x x x x x x x
 Blood pressure x x x x x x x x x
 Fasting glucose, insulin x x x
 Fasting cholesterol, HDL, LDL, triglycerides x x x
 Haemoglobin A1c x x x
 OGTT x x
Other
 Heart rate x x x x x x x x x
 PANSS x x x
 GAF x x x
 SIMPAQ/IPAQ x x x
 AQOL x x x
 TOPF x x
 CVLT-II short form x x
 Symbol Digit Modalities Test x x
 Controlled Oral Word Association Test x x
 Trail Making Test x x
 Food Craving Inventory x x x
Other
 Drug compliance x x x x x x x x
 Blood (other)—FBC (including WCC, neutrophils), ELFT (including serum bicarbonate and lactate) clozapine/nor clozapine levels x x x

AQoL, Assessment of Quality of Life; CVLT-II, The California Verbal Learning Test second edition; ELFT, Electrolytes and Liver Function Tests; FBC, full blood count; GAF, Global Assessment of Functioning; HCG, human chorionic gonadotropin; HDL, high-density lipoprotein; IPAQ, International Physical Activity Questionnaire; LDL, low-density lipoprotein; OGTT, Oral Glucose Tolerance Test; PANSS, Positive and Negative Syndrome Scale; SAFTEE-SI, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry; SIMPAQ, Simple Physical Activity Questionnaire; TOPF, Test of Premorbid Functioning.