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. 2017 Jan 13;5:86–91. doi: 10.1016/j.conctc.2017.01.004

Table 4.

Study hypothesis, design, endpoint and statistical analysis.

Treatment ARM1 Treatment ARM 2 Endpoints Statistical analysis
Primary hypothesis
  • -

    6-week Treatment phase: 10 Hz rTMS +50 mg Sertraline once daily

  • -

    6-week Maintenance phase: 10 Hz rTMS + Sertraline
  • -

    6-week Treatment phase: Sham rTMS protocol +50 mg Setraline

  • -

    6-week Maintenance phase: Sham rTMS protocol +50 mg Sertraline

 Primary:
Reduction of 50% baseline HAM-D17 scale score
 Unpaired t-test based on Central Limit Theorem
Treatment ARM 2
 Treatment ARM 3
 Endpoints
 Statistical analysis
Ancillary hypothesis
  • -

    6-week Treatment phase: Sham rTMS protocol +50 mg Setraline

  • -

    6-week Maintenance phase: Sham rTMS protocol +50 mg Sertraline
  • -

    6-week treatment phase: 10 Hz rTMS protocol + Placebo

  • -

    6-week maintenance phase: 10 Hz rTMS + placebo

 Secondary:
Reduction of 50% baseline HAM-D17 scale score after 6 weeks and 12 weeks time points		 Unpaired t-test based on Central Limit Theorem