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Dose Escalation/Change in Study Medication and Management of Side Effects between Medication Steps, based on Efficacy and Tolerability.
| Efficacy | |||
|---|---|---|---|
| Yes (PGSC* 4,5) | No (PGSC 1-3) | ||
| Tolerability | Yes | No change in medication No need to manage side effects | Dose escalate or change study medication |
| No | No change in medication Aggressively manage side effects | Dose escalate/change study medication and aggressively manage side effects | |
PGSC=Patient Global Symptom Control rating
