Table 3.

Clinical reasons for withdrawal of participants

Illness requiring hospitalization that is likely to preclude further study participation.

Known side-effects of the trial drug which are considered intolerable by the participant.

Extreme electrolyte disturbances or renal dysfunction.

Hypotension—If the patient has symptoms consistent with hypotension and clinic systolic BP is <110 mm Hg or the change in BP from previous reading is >30 mm Hg, and in the opinion of the investigator there is no self-limiting reason for hypotension (e.g., episode of dehydration, climatic conditions).

Abbreviation: BP, blood pressure.