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Table 2 Timeline, study treatment, study visits and medical procedures

From: Study protocol of a phase II clinical trial of oral metformin for the intravesical treatment of non-muscle invasive bladder cancer

Required InvestigationsPrestudyTelephone calls6 weeks after start treatment3 months after start treatment (end of treatment)
Written informed consentX   
DemographicsX   
Overall medical historyX   
ECOG/WHO performance statusXXXX
Adverse events XXX
EORTC QLQ-NMIBC24X XX
SF-36 quality of lifeX XX
Medication diary XXX
Physical:    
 Physical examinationX XX
 TURBX  X
Haematology:    
 Complete blood countsX XX
 PT, APTTX   
Clinical chemistry:    
 Renal functionX XX
 Liver functionX XX
 Serum glucoseX XX
 HbA1cX  X
 InsulinX  X
 IGF-1X  X
 IGF binding protein-3X  X
Other Investigations:    
 Metformin concentration in serum  XX
 Metformin concentration in urine  XX
 UrinalysisX XX
 Pathological review of biopsiesX  X
  1. Abbreviations: ECOG Eastern Cooperative Oncology Group, IGF insulin growth factor, WHO World Health Organisation
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