HIGHLIGHTS
- who: Alina Bergholz from the The proposed trial will be conducted in accordance with the ethical principles based on the Declaration of Helsinki [18] and the ICH , guidelines for good clinical practiceThe trial was approved by the ethics committee Hamburg (Ethikkommission der u00c4rztekammer Hamburg, Hamburg, Germany, registration number, BO-ff ) acting as the primary ethics committee for this trial. Secondary ethics committee approvals will be obtained for each trial site before patient recruitment starts. The trial was registered at(NCT05416944) on June, . This article adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (Additional . . .
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