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Table 1 Characteristics of the NI trials

From: Phase IV non-inferiority trials and additional claims of benefit

  N (%)
  (Unless stated otherwise)
I. Type of Drugs  
 Anti-infective 9 (22)
 Cardiovascular system 9 (22)
 Systemic hormonal preparations 5 (12)
 Vaccines 5 (12)
 Musculo-skeletal system 2 (5)
 Nervous system 3 (7)
 Antineoplastic 2 (5)
 Others 6 (15)
II. Type of trial initiators  
 Non-pharmaceutical industry 12 (29)
 Pharmaceutical industry 25 (61)
 Not clear 4 (10)
III. Number of trial subjects (median (interquartile range)) 316 (196–629)
IV. Type of analysis  
 Both ITT and PP 19 (46)
 ITT only 13 (32)
 PP only 8 (20)_
 Unclear 1 (2)
V. Conclusion of the trial  
 Non-inferiority 30 (73)
 Superiority 2 (5)
 Inferiority 6 (15)
 Others 3 (7)
VI. Mentioned additional benefit 22 (54)