In this interim analysis, a reduction in the number of MDEs was observed for all except two participants (both in subtherapeutic dose cohorts), who had reported MDEs in the pretreatment period. The relative risk for MDEs was reduced by 70% during the treatment period of the dose-optimization ...
All patients enrolled in the study provided written informed consent, and the study was conducted in accordance with applicable International Conference on Harmonisation Good Clinical Practice Guidelines, the principles of the Declaration of Helsinki and any applicable local laws and regulations. The protoc...
Those who wish to take part in the trial will be asked to sign and date the written consent form, supported by the research nurse over the telephone, and return it along with their completed baseline questionnaire to the nurse in a pre-paid envelope. Those who do not wish to take part ...
Ethical approval was provided by the local institutional Human Ethics Committee (H13563) and the trial was registered on the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/—Trial Id: ACTRN12619001519145) on November 4, 2019. Each respondent gave written informed consen...
review board for each participating study center. All patients signed a written informed consent before study-specific procedures. The study is registered in ClinicalTrials.gov asNCT02034110and EudraCT as 2013-001705-87. The study protocol can be located in theSupplementary Informationfor this ...
Participants were provided written instructions to limit their intake of PUFA intake during the trial. All participants were provided and instructed to take two vitamin B complex supplements per day each containing 500 mcg of vitamin B12, 50 mg of vitamin B6 and 400 mcg of folic acid (...
The study conforms to the requirements of the 1964 Declaration of Helsinki. The research protocol was approved by the ethics committees at each site (Table 1), and all participants gave written informed consent. Full details of the study design and eligibility criteria have been published ...
Individuals will be asked to provide written informed consent for HIV testing as is done routinely at health facilities. In addition, a written information leaflet will be provided to all households. Full ethical review of the trial protocol has been carried out by the ethics committees of the ...
Patients must be capable of giving written informed consent, which includes compliance with the study requirements. Patients are not eligible if they have a history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing >Grade...
, and was performed in full accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki, and all patients gave written informed consent. Propensity score model Baseline factors were compared between the MSAF < 1% and MSAF ≥ 1% subgroups. Factors with notable...