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Table 1 Schedule of Events

From: Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial

Timelines + 3 days

Day -7

Day 0

Day 7

Day 14

Day 21

Day 28

Day 35

Day 42

Day 49

Day 56

Day 63

Day 70

Day 77

Day 84

Day 91

Day 98

Day 105

Day 280+ 7

VISIT

Screen

Week 0 Rand

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 9

Week 10

Week 11

Week 12

Week 13

Week 14

Week 15 or Term

Week 40 F/UP

Informed Consent

x

                 

Medical History

x

                 

Demographics

x

                 

Inclusion/Exclusion

x

x

                

Height

x

            

x

   

x

Weight & BMI score

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Physical Exam

x

               

x

 

Randomization

 

x

                

Vital Signs

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Hematology & Chemistry*

x

  

x

 

x

   

x

   

x

  

x

 

HBA1C

   

x

            

x

 

Multistick Urinalysis

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

Urine for Pregnancy

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

Electrocardiogram (EKG)

x

  

x

 

x

          

x

 

Adverse Events

  

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Concomittant Meds (mg)

x

1.25 → 2.5

5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

5.0

2.5

0

0

0

Dispense Study Med

 

x

x

x

x

x

x

x

x

x

x

x

x

x

x

   

AIMS

  

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

Psychological Measures

                  

EAT-26

 

x

     

x

     

x

  

x

x

CDI **

 

x

     

x

     

x

  

x

x

MASC **

 

x

     

x

     

x

  

x

x

CAPI

 

x

     

x

     

x

  

x

x

CBCL**

 

x

     

x

     

x

  

x

x

EDS3

 

x

     

x

     

x

  

x

x

  1. *namely CBC and diff, electrolytes, Mg, Ca, P04, BUN, Cr, fasting glucose, Albumin, Ferritin, vit.B12, RBC folate, FSH, LH, estradiol, prolactin, βHCG, TSH, INR, cholesterol and triglycerides, ALT, AST and Alk. Phos. If more than 2 weeks have elapsed between Screen labs and Baseline (week 0), repeat Screen labs work prior to or at Baseline Visit (with the exception of bone mineral density)
  2. ** If CDI, MASC and CBCL have been completed at Screen Visit and it is < 2 weeks, these measures may not be repeated at week zero.
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