Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan

Table 4 Protocol deviations

	Step1		Step2				Step3
	Weeks 1 to 3		Weeks 3 to 9				Weeks 9 to 25
	50 mg	100 mg	Continue sertraline	Augment	Switch	Remitted
	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)
B. Treatment deviation
B1. Prohibited concurrent treatments
B2. Impossible to randomize at week 3
B3. No tolerability to sertraline at step 1
B4. Mania at week 1 though week 3
B5. Mania or diagnosis of schizophrenia or dementia at week 3 through 25
C. Stopping intervention and assessment
C1. The participant wishes to stop the protocol treatment.
C2. The trial physician judges that it is difficult to continue the protocol treatment because of the emergence of serious adverse events (SAE) as defined below.
C3. The trial physician judges that the risk outweighs the benefit in continuing the protocol treatment even when no SAE is reported.
C4. The participant becomes pregnant and the trial physician judges that the risk outweighs the benefit in continuing the protocol treatment.
C5. The trial physician judges that it is inappropriate to continue the protocol treatment for any other reason.
D.
D1. The participant withdraws consent to receiving protocol assessments, regardless of whether he/she is continuing the protocol treatment.
E.
E1. Violation of allowance in timing of assessments of outcomes

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