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Table 3 Assessment schedule – for all patients recruited

From: Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial

Observation/Investigation Screening Treatment Phase (weeks) Follow-up (Post-treatment phase, months)
 Study visits 0 2 4 6 8 12 16 19 22 26 3 6 9 12 15 18 21 24
 Time window (days)   ±3 ±3 ±3 ±3 ±7 ±7 ±7 ±7 ±7 ±14 ±14 ±14 ±14 ±14 ±14 ±14 ±14
Demographics X                  
 Written or witnessed informed consent X                  
 Patients eligible criteria judgement X                  
 Medical history and clinical assessment X X X X X X X X X X X X X X X X X X
 Concomitant diseases and medication taken assessment X X X X X X X X X X X X X X X X X X
 Randomized assignment X                  
Efficacy evaluation                   
 Bacteriological test Sputum smear X X X X X X X X X X X X X X X X X X
Sputum culture X X X X X X X X X X X X X X X X X X
 X-ray X     X    X   X   X   X   X   X
Safety evaluation                   
 Complete blood count X   X   X X X X X X         
 Urinalysis X   X   X X X X X X         
 Hepatic and renal functions X   X   X X X X X X         
 Electrocardiograph (ECG) X   X   X X X X X X         
 Body weight X X X X X X X X X X X X X X X X X X
 Adverse effect record   X X X X X X X X X X X X X X X X X
Others                   
 Drug distribution log X X X X X X X X X          
 Drug retrieve log   X X X X X X X X X         
  1. X indicates assessments required at particular visits