Prohibited concomitant medication
CRF
EVENT, DISEASES, CRF
We will try to avoid combining drugs as much as possible, especially combining medications that have a strong impact on the judgment of the trial results (effectiveness and safety). However, in case of AE, deterioration of the original condition, or complication/new onset of other serious diseases during the trial, the investigator should promptly combine the drugs and actively carry out rescue treatment. If the subject meets the withdrawal criteria, the investigator should make proper arrangements for the subject to withdraw from the trial. All the concomitant medication (including prescription and over-the-counter medications) should be recorded in the case record form (CRF) during the trial, including details of drug name, single dose, frequency of administration, routine of administration, reason for administration, start and end time of administration, etc. If the dosage of concomitant medication changes, it should also be recorded in the CRF. In particular, the combined drug use in the event of an AE should be recorded and reported in a timely way.