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CycloME
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== Study outcome measures == Primary Outcome Measures: * Self reported fatigue score, and * overall response as the effect of treatment on ME/CFS symptoms, both measured within a 12 months follow-up period.<ref name="PhaseII" /><ref name="Rekeland2020" /> Secondary Outcome Measures: *[[Short-Form 36]] ([[SF-36]]), recorded at baseline, and at 3, 6, 9 and 12 months follow-up, *Physical activity via a Sensewear armband, recorded at baseline, at 7-9 months, and at 11-12 months, *[[Cardiopulmonary exercise test]]s for two following days, performed at baseline, and repeated at 7-9 months, and 11-12 months, *Self-recorded Function level, recorded at baseline, and at 3, 6, 9 and 12 months follow-up, *[[Fatigue Severity Scale]] (FSS), completed at baseline, 3, 6, 9 and 12 months, *Longest duration of continuous response duration, measured by a self-reported fatigue score ≥ 4,5 (for at least 6 consecutive weeks) within 12 months follow-up, *Sustained clinical response at 12 months, defined as a fatigue score of at least 4.5 at 12 months follow-up, and *Safety and tolerability, including [[adverse event]]s, measured by patient history, physical exam, and lab tests, performed every four weeks the first six months, thereafter at 6, 9 and 12 months follow-up. Adverse events were likely to include hair loss, vomiting, [[diarrhea]], jaundice, leukopenia, [[anemia]], thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis, disturbed ovarian function. Information collection on possible toxicity continued after the formal 12 months study period.<ref name="PhaseII" /><ref name="Rekeland2020" /> The final follow up continued 3-4 years.<ref name="Rekeland2020" />
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