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Table 3 Withdrawal criteria for the Onkyeong-tang (OKT) clinical trial

From: Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Withdrawal criteria

1. Those whose compliance is less than 70%

2. Those who become pregnant during the trial period

3. Those who need surgery or hospitalization due to accidents or other diseases

4. Patient withdrawal of consent

5. Those who have used forbidden medicines or treatments such as anticoagulants, psychotropic drugs, or other medications or treatments that may have effects on the symptoms of CHF

6. Those who need standard treatment because of the aggravation of CHF symptoms

7. Occurrence of SAEs

8. Occurrence of other inevitable situations that may make it difficult to continue the trial process

9. Principal investigator’s (PI’s) judgement to discontinue the trial due to some factors affecting the study results